Acceptability, preference, tolerance and clinical efficacy of dipropionate beclomethasone delivered by two inhalation devices in chronic asthma patients: Clenil pulvinal versus Miflasona Aerolizer Background: Approximately half of all asthmatic patients adhere to their prescribed treatment regimen, which makes noncompliance with treatment one of the main problems associated with the disease. It is possible that inhalation devices combining technological advances with comfort and simplicity of use could increase treatment compliance. Objective: To compare the acceptability of and preference for two inhalation devices (Pulvinal and Aerolizer), as well as to evaluate the efficacy of and tolerance for beclomethasone dipropionate when delivered by these two systems. Method: A multicenter, randomized, crossover parallel study was carried out involving 83 patients with stable asthma. Patients received 500-1000 g/day of beclomethasone dipropionate. After a 2-week run in, the patients were randomized to begin a 4-week crossover treatment period with equivalent doses of Clenil Pulvinal (CP) or Miflasona Aerolizer (MA). Results: Both groups showed improvement in dyspnea and FEV1, and acceptability was considered good or excellent in both groups. Of the patients studied, 50.6% preferred CP, and 39% preferred MA. In their future treatment regimes, 54.5% would choose the CP and 37.7% the MA. Conclusion: Clinical efficacy and acceptability were comparable between CP and MA.

Keywords: Asthma/therapy. Beclomethasone/ administration & dosage. Randomized controlled trials. Treatment Outcome.

Objective: To evaluate treatment compliance and use of inhaled medications of patients with asthma receiving complementary pharmaceutical care. Methods: A controlled prospective parallel study involving a study group and a control group. We selected 60 patients with persistent asthma and using metered-dose inhalers (MDIs), dry powder inhalers (DPIs) or both. The patients were evaluated three times over 60 days. Instructions were provided to the patients in the study group at all visits but only at the first visit to those in the control group. The patients using < 80% or > 120% of the total number of prescribed doses were classified as noncompliant. The inhalation technique was quantified by a scoring system. A satisfactory technique was defined as a score higher than 7 (maximum, 9) for MDIs and higher than 4 (maximum, 5) for DPIs. Results: The final study sample comprised 28 study group patients and 27 control group patients, of whom 18 (64.3%) and 20 (74.7%), respectively, were considered treatment compliant. From the first to the third visits, there were increases, in the study and control groups, in the median MDI-use score (from 3 [range, 0-5] to 8 [range, 8-9]; p < 0.001; and from 5 [range, 2-6] to 7 [range, 6-8]), as well as in the median DPI-use score (from 3 [range, 2-4] to 5 [range, 4-5] and from 3 [range, 2-4] to 4 [range, 3-5]). Conclusions: The counseling provided by the pharmacist to the patient was important to assist in the implementation of the appropriate inhalation technique, especially for MDI use.

Keywords: Asthma; Pharmaceutical services; Administration, inhalation;Metered dose inhalers; Medication adherence.

Objective: Mometasone furoate (MF) is a new potent synthetic inhaled corticosteroid. Internationally, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. Methods: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. Results: No significant differences were observed between the two groups regarding the primary endpoints (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function). Conclusions: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma. Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers.

Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers. (ClinicalTrials.gov identifier: NCT00975741 [http://www.clinicaltrials.gov/])

Objective: To evaluate knowledge of and techniques for using prescribed inhalation devices among patients with asthma or COPD treated at a tertiary teaching hospital. Methods: Patients were assessed after medical visits, and their physicians were blinded to this fact. Patients were asked to demonstrate their inhaler technique and were then interviewed regarding their knowledge of inhalation devices, control of the disease and instructions received during medical visits. Results: We included 120 volunteers: 60 with asthma and 60 with COPD. All of the asthma patients and 98.3% of the COPD patients claimed to know how to use inhaled medications. In the sample as a whole, 113 patients (94.2%) committed at least one error when using the inhalation device. Patients committed more errors when using metered-dose inhalers than when using the dry-powder inhalers Aerolizer® (p < 0.001) or Pulvinal® (p < 0.001), as well as committing more errors when using the Aerolizer® inhaler than when using the Pulvinal® inhaler (p < 0.05). Using the metered-dose, Pulvinal® and Aerolizer® inhalers, the COPD group patients committed more errors than did the asthma group patients (p = 0.0023, p = 0.0065 and p = 0.012, respectively). Conclusions: Although the majority of the patients claimed to know how to use inhalation devices, the fact that 94.2% committed at least one error shows that their technique was inappropriate and reveals a discrepancy between understanding and practice. Therefore, it is not sufficient to ask patients whether they know how to use inhalation devices. Practical measures should be taken in order to minimize errors and optimize treatment.

Keywords: Metered dose inhalers; Nebulizers and vaporizers; Asthma; Pulmonary disease, chronic obstructive.

Objective: To compare a once-daily long-acting β2 agonist (indacaterol 150 µg) with a once-daily long-acting anticholinergic (tiotropium 5 µg) in terms of their effects on exercise endurance (limit of tolerance, Tlim) in patients with moderate COPD. Secondary endpoints were their effects on lung hyperinflation, exercise-related dyspnea, and daily-life dyspnea. Methods: This was a randomized, single-blind, crossover pilot study involving 20 patients (mean age, 60.9 ± 10.0 years; mean FEV1, 69 ± 7% of predicted). Spirometric parameters, Transition Dyspnea Index scores, Tlim, and exertional dyspnea were compared after three weeks of each treatment (with a one-week washout period between treatments). Results: Nineteen patients completed the study (one having been excluded because of COPD exacerbation). Improvement in Tlim from baseline tended to be greater after treatment with tiotropium than after treatment with indacaterol (96 ± 163 s vs. 8 ± 82 s; p = 0.06). Tlim significantly improved from baseline after treatment with tiotropium (having increased from 396 ± 319 s to 493 ± 347 s; p = 0.010) but not after treatment with indacaterol (having increased from 393 ± 246 to 401 ± 254 s; p = 0.678). There were no differences between the two treatments regarding improvements in Borg dyspnea scores and lung hyperinflation at "isotime" and peak exercise. There were also no significant differences between treatments regarding Transition Dyspnea Index scores (1.5 ± 2.1 vs. 0.9 ± 2.3; p = 0.39). Conclusions: In patients with moderate COPD, tiotropium tends to improve Tlim in comparison with indacaterol. No significant differences were observed between the two treatments regarding their effects on lung hyperinflation, exercise-related dyspnea, and daily-life dyspnea. Future studies, including a larger number of patients, are required in order to confirm our findings and explore mechanistic explanations. (ClinicalTrials.gov identifier: NCT01693003 [http://www.clinicaltrials.gov/])

Keywords: Pulmonary disease, chronic obstructive; Exercise; Bronchodilator agents.

Background: Pulmonary rehabilitation is widely recommended for the treatment of chronic obstructive pulmonary disease. Objective: To evaluate the efficacy of pulmonary rehabilitation in improving exercise capacity, respiratory muscle strength and quality of life of chronic obstructive pulmonary disease patients. Method: This was an open, non-randomized clinical trial involving 27 clinically stable ex-smokers with chronic obstructive pulmonary disease who were enrolled in a pulmonary rehabilitation program. All were evaluated before and after pulmonary rehabilitation. Results: Mean age was 65 ± 5 years, mean body mass index was 25 ± 4 kg/m2, mean forced expiratory volume in one second was 55 ± 25% of predicted, mean ratio between forced expiratory volume in one second and forced vital capacity was 50 ± 12%, and mean arterial oxygen tension was 70 ± 7 mmHg. Comparison of pre- and post-pulmonary rehabilitation values revealed improvement in the distance walked in the 6-minute walk test (513 ± 99 m vs. 570 ± 104 m), maximum upper limb load (2 ± 1 kg vs. 3 ± 1 kg) and maximal inspiratory pressure (-89 ± 23 cmH2O vs. -102 ± 23 cmH2O), as well as in the activity domain, impact domain and total score on the Saint George's Respiratory Questionnaire. Conclusion: Pulmonary rehabilitation, when performed with care and with a focus on physical training, is efficacious in increasing not only the distance walked in the 6-minute walk test but maximum upper limb load, maximal inspiratory pressure and quality of life as well.

Keywords: Key words: Pulmonary rehabilitation. Chronic obstructive pulmonary disease. Quality of life. Respiratory muscles.

Objective: Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR), fluticasone alone (FLU), and the single-capsule combination of fluticasone/formoterol (FLU/FOR) on lung function in patients with mild-to-moderate persistent asthma. Methods: This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L) at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use. Results: We randomized 243 patients to three groups: FLU/FOR (n = 79), BUD/FOR (n = 83), and FLU (n = 81). In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49), whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52). Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002). The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations. Conclusions: The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma. (ClinicalTrials.gov Identifier:NCT01202084 [http://www.clinicaltrials.gov/])

Keywords: Asthma; Steroids; Bronchodilator agents; Administration, inhalation.

Objective: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination, in comparison with budesonide alone, in patients with uncontrolled asthma. Methods: This was a randomized, double-blind, multicenter, phase III, parallel clinical trial, comparing the short-term efficacy and safety of the combination of budesonide (400 μg) and formoterol (12 μg), with those of budesonide alone (400 μg), both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma. The age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups. The treatment consisted of the administration of the medications twice a day for 12 weeks. The primary outcome measures were FEV1, FVC, and morning PEF. We performed an intention-to-treat analysis of the data. Results: In comparison with the budesonide-only group patients, those treated with the budesonide-formoterol combination showed a significant improvement in FEV1 (0.12 L vs. 0.02 L; p  =   0.0129) and morning PEF (30.2 L/min vs. 6.3 L/min; p  = 0.0004). These effects were accompanied by good tolerability and safety, as demonstrated by the low frequency of adverse events, only minor adverse events having occurred. Conclusions: The single-capsule combination of budesonide-formoterol appears to be efficacious and safe. Our results indicate that this formulation is a valid therapeutic option for obtaining and maintaining asthma control. (ClinicalTrials.gov Identifier: NCT01676987 [http://www.clinicaltrials.gov/])

Keywords: Asthma; Budesonide; Adrenergic beta-2 receptor agonists.

Objective: To evaluate the use of inhaler devices by patients with severe asthma treated via the Programa para o Controle da Asma e Rinite Alérgica na Bahia (ProAR, Bahia State Asthma and Allergic Rhinitis Control Program), recording the frequency of their errors in performing key steps and the relationship between such errors and the lack of asthma control. Methods: A cross-sectional study involving 467 patients enrolled in the ProAR in the city of Salvador, Brazil. The devices evaluated were metered dose inhalers (MDIs), with or without a spacer, and dry powder inhalers (DPIs; Pulvinal® or Aerolizer®). For the assessment of the inhalation technique, a checklist was used; the patients were asked to demonstrate the technique so that an interviewer could observe all of the steps performed. For the assessment of asthma control, we used the 6-item asthma control questionnaire. Results: Most of the patients showed appropriate inhalation techniques when using the devices. When using an MDI, few patients made mistakes in the key step of "coordinating activation and inhalation" (5.2% and 9.1% with and without the use of a spacer, respectively). During Pulvinal® use, 39% of the patients did not inhale quickly and deeply, compared with only 5.8% during Aerolizer® use. Of the patients that made use of Aerolizer® alone, 71.3% appropriately performed all of the essential steps, and their asthma was controlled. Conclusions: Most of the patients in this sample, all of whom had been submitted to periodic checks of their inhalation technique (as part of the program), used the devices appropriately. Proper inhalation technique is associated with asthma symptom control.

Keywords: Asthma; Administration, inhalation; Metered dose inhalers; Dry powdered inhalers.

Background: Patients with chronic obstructive pulmonary disease usually present intolerance to physical exertion due to ventilatory limitation. L-carnitine has been used to enhance aerobic capacity in patients with chronic diseases, but no study seems to be available for this patient population. Objective: To evaluate the influence of L-carnitine supplementation (2 g/day) in chronic obstructive pulmonary disease patients undergoing physical training three times a week for six weeks. Method: Patients (mean age 69 ± 7 years, n = 30) with stable chronic obstructive pulmonary disease and < 65% of predicted forced expiratory volume in 1 second (FEV1) were separated into three groups of 10 patients each. Group 1 (G1, n = 10) received physical training and L-carnitine (2 g/day), group 2 (G2, n = 10) received physical training and placebo, and group 3 (G3, n = 10) received only L-carnitine (2 g/day). Spirometry and a 6-minute walking distance test were performed before and after intervention. Plasma levels of free carnitine were measured at the beginning and end of the study. Results: A significant increase in walking distance was found only in G1 and G2 (421 ± 100 to 508 ± 80.7 and 496 ± 78.7 to 526 ± 64.3 respectively). In addition, heart rates during physical training sessions were found to be significantly lower in G1 when compared to G2. There were no significant changes in spirometric variables, oxygen saturation or dyspnea in any group. Plasma levels of free L-carnitine were found to increase only in G3 (59.2 ± 13.8 to 102.3 ± 15.3 mmol/L). Conclusion: Oral L-carnitine supplementation combined with physical training may improve tolerance to physical exertion in chronic obstructive pulmonary disease patients.

Keywords: Chronic obstructive pulmonary disease. Carnitine/therapeutic use. Spirometry/methods. Exercise. Walking.

Asthma is characterized by variable airflow obstruction, hyperresponsiveness of airways to endogenous or exogenous stimuli and inflammation. Inadequacy of the techniques to use different inhalation devices is a cause of no response to treatment. The main purpose of this study was to evaluate how 20 medical students, 36 resident physicians on Internal Medicine/Pediatrics, and 40 asthma patients used three devices for inhalation therapy containing placebo. All patients were followed at the Pulmonary Outpatient Service of Botucatu Medical School and had been using inhaled medication during the last six months. The following devices were evaluated: metered dose inhalers (MDI), dry powder inhalers (DPI), and MDI attached to a spacer device. A single observer applied a protocol containing the main steps necessary to obtain a good inhaler technique to follow and grade the use of different devices. Health care professionals tested all three devices and patients tested only the device being used on their management. MDI was the device best known by doctors and patients. MDI use was associated with errors related to the coordination between inspiration and device activation. Failure do exhale completely before inhalation of the powder was the more frequent error observed with DPI use. In summary, patients have not been receiving repeated instruction on how to use inhaled medication and health care professionals are not well prepared to adequately teach their patients.

Objective: To determine the oxygen outflow delivered by seven different models of manually operated self-inflating resuscitation bags (with and without an oxygen reservoir connected), which were tested using different oxygen supply rates without manipulating the bag, by simulating their use in patients breathing spontaneously. Methods: The oxygen outflow was measured using a wall oxygen flow meter and a flow meter/respirometer attached to the bag, together with another flow meter/respirometer attached to the patient connection port. The resuscitation bags that allow the connection of an oxygen reservoir were tested with and without this device. All resuscitation bags were tested using oxygen supply rates of 1, 5, 10, and 15 L/min. Statistical analyses were performed using analysis of variance and t-tests. Results: The resuscitation bags that allow the connection of an oxygen reservoir presented a greater oxygen outflow when this device was connected. All resuscitation bags delivered a greater oxygen outflow when receiving oxygen at a rate of 15 L/min. However, not all models delivered a sufficient oxygen outflow even when the two previous conditions were satisfied. Conclusions: Of the resuscitation bags studied, those that allow the connection of an oxygen reservoir must have this reservoir connected to the bag when used as a source of oxygen in nonintubated spontaneously breathing patients. All of the models studied should receive oxygen at a rate ≥ 15 L/min. It is not safe to use manually operated self-inflating resuscitation bags for this purpose without knowing their characteristics.

Keywords: Oxygen/administration & dosage; Resuscitation; Equipment and supplies; Respiration; Intensive care.

Objective: To assess possible alterations in the tidal volume and peak inspiratory pressure delivered by seven models of manually operated self-inflating resuscitation bags as a function of the oxygen supply rate used. Methods: The resuscitation bags tested were the following: Oxigel, models A and B; CE Reanimadores; ProtecSolutions; Missouri; Axmed; and Narcosul. For the measurements, a wall oxygen flow meter, a flow meter/respirometer, a resuscitation bag, a sensor (Tracer 5 unit), and a test lung were connected. In addition, the Tracer 5 unit was connected to a notebook computer. Oxygen supply rates of 1, 5, 10, and 15 L/min were used. Results: The tidal volume delivered by the Oxigel model A resuscitation bag when receiving oxygen at a rate of 15 L/min was approximately 99% greater than that delivered when receiving oxygen at a rate of 1 L/min. Similarly, peak inspiratory pressure was approximately 155% greater. Under the same conditions, the tidal volume delivered by the Narcosul resuscitation bag was 48% greater, and peak inspiratory pressure was 105% greater. The remaining resuscitation bags tested showed no significant alterations in the tidal volume or peak inspiratory pressure delivered. Conclusions: Under the resistance and compliance conditions used, the resuscitation bags in which the oxygen inflow is directed to the interior of the bag had the patient valve stuck at the inspiratory position when receiving oxygen at a rate ≥ 5 L/min, significantly increasing the tidal volume and peak inspiratory pressure delivered. This did not occur with the resuscitation bags in which the oxygen inflow is directed to the exterior of the bag.

Keywords: Oxygen/administration & dosage; Resuscitation; Equipment and supplies; Pulmonary ventilation; Intensive care.

Two spacer devices for aerosol inhalation were compared by a crossover study of FEV 1 response to 200 μg of salbutamol in 20 asthmatics evaluated in separate days. Fisonair ® (750 ml reservoir) use led to an average 0.32 L increase in FEV 1, which was significantly higher than the 0.26 L obtained with Jet® (103 ml reservoir) (p = 0.02). Bronchodilator response with Jet® was 21% lower (CI: -7 to -35%) than with Fisonair ® .

Keywords: Asthma. Aerosols. Delivery systems.

Objective: To determine the efficacy of the scoring system, recommended by the Brazilian National Ministry of Health (NMH), for the diagnosis of pulmonary tuberculosis (TB) in children and adolescents, regardless of their HIV status. Methods: This was a cross-sectional analytical study carried out between January of 2002 and December of 2006, involving 239 individuals less than 15 years of age. The patients were divided into four groups: latent TB (LTB group; n = 81); no-TB (NTB group; n = 41); TB group (n = 104); and TB/HIV group (n = 13). We studied the clinical, radiological and laboratory findings according to the scoring system. Results: Reports of fever, cough, asthenia and weight loss for at least two weeks were significantly higher in the TB group (p < 0.0001). The proportion of cases with a history of any contact and household contact with a TB patient was, respectively, 95.0% and 86.1% in the TB group, versus 75.0% and 58.3% in the TB/HIV group. In the TB and TB/HIV groups, respectively, chest X-rays revealed parenchymal alterations in 75.0% and 53.9%, revealing combined parenchymal/lymph node alterations in 18.2% and 30.8%. There were no significant differences among the groups regarding the tuberculin skin test results. In the TB group, 16.3% of the patients were malnourished (p < 0.005 vs. the LTB group). The mean NMH system scores in the LTB, NTB, TB and TB/HIV groups were, respectively, 24.2, 18.5, 45.3 and 41.5. Conclusions: The NMH system scores were significantly higher in the TB and TB/HIV groups than in the other two groups. Therefore, this scoring system was valid for the diagnosis of pulmonary TB in this population, regardless of HIV status.

Keywords: Tuberculosis/diagnosis; HIV seropositivity; Diagnostic techniques and procedures.

Background: Short-acting b2 agonists delivered by metered-dose inhaler (MDIs) are the drugs usually used for the reversal of methacholine-induced bronchoconstriction. The b2 agonists that are delivered by dry-powder inhaler (DPI) can be an efficacious option. Objective: To evaluate the effectiveness and speed of action of salbutamol delivered by DPI (Pulvinal; Butoventâ), in comparison to salbutamol delivered by MDI, in reversing methacholine-induced bronchoconstriction. Method: Sixty successive methacholine-induced bronchoconstriction patients who presented a decrease of at least 20% in forced expiratory volume (FEV1) were evaluated prospectively. Of these 60 patients, we randomized 30 (first group) to receive 200 mcg of salbutamol by MDI and 30 (second group) to receive 200 mcg of salbutamol by DPI (Pulvinal). Both drugs were administered with the objective of reversing bronchoconstriction during the final phase of a bronchoprovocation test. The FEV1 values obtained at 1 and 5 minutes after bronchodilator administration were evaluated. Results: The groups were comparable in gender distribution, age, weight, dose level provoking a 20% drop in FEV1 (first group: 1.3 mg; second group: 1.19 mg; p = 0.79) and post-methacholine FEV1 (first group: 2.03 l; second group: 1.99 l; p = 0.87), with no statistically significant differences between the two groups. In the first group (MDI), the mean increase in FEV1 was 16.2% (at 1 minute) and 22.2% (at 5 minutes), and in the second group (DPI) it was 17% (at 1 minute) and 23.6% (at 5 minutes). There was no statistically significant difference between the groups (p = 0.8). Conclusion: The b2-agonists delivered by DPI (Pulvinal) present the same bronchodilator efficacy and speed of action as do those delivered by the more traditional MDI method.

Keywords: Asthma. Bronchodilator agents/administration & dosage. Albuterol/administration & dosage. Methacholine chloride/administration & dosage. Respiratory therapy/methods. Administration, inhalation/methods. Prospective studies.

Objective: To validate two scores quantifying the ability of patients to use metered dose inhalers (MDIs) or dry powder inhalers (DPIs); to identify the most common errors made during their use; and to identify the patients in need of an educational program for the use of these devices. Methods: This study was conducted in three phases: validation of the reliability of the inhaler technique scores; validation of the contents of the two scores using a convenience sample; and testing for criterion validation and discriminant validation of these instruments in patients who met the inclusion criteria. Results: The convenience sample comprised 16 patients. Interobserver disagreement was found in 19% and 25% of the DPI and MDI scores, respectively. After expert analysis on the subject, the scores were modified and were applied in 72 patients. The most relevant difficulty encountered during the use of both types of devices was the maintenance of total lung capacity after a deep inhalation. The degree of correlation of the scores by observer was 0.97 (p < 0.0001). There was good interobserver agreement in the classification of patients as able/not able to use a DPI (50%/50% and 52%/58%; p < 0.01) and an MDI (49%/51% and 54%/46%; p < 0.05). Conclusions: The validated scores allow the identification and correction of inhaler technique errors during consultations and, as a result, improvement in the management of inhalation devices.

Keywords: Asthma; Dry powder inhalers; Metered dose inhalers; Validation studies.

Objective: To determine the efficacy of using forced expiratory volume in six seconds (FEV6) as a surrogate for forced vital capacity (FVC) in the diagnostic screening for chronic obstructive pulmonary disease (COPD) by comparing FEV1/FVC ratios with FEV1/FEV6 ratios. Methods: In November of 2003, on World COPD Day, we conducted a campaign of diagnostic screening for COPD. The participants completed the clinical questionnaire of the Global Initiative for Obstructive Lung Disease, and those who responded affirmatively to at least three questions underwent spirometry. Results: A total of 134 individuals responded to three questions affirmatively and underwent spirometry. Of those, 59 were excluded: 45 for being non-smokers and 14 due to the fact that their tests did not meet the American Thoracic Society criteria for satisfactory spirometry. The number of tests in which the FEV1/FEV6 ratio was below 70% was similar to that found for the FEV1/FVC ratio. The sensitivity of FEV1/FEV6 in diagnosing airway obstruction (defined as FEV1/FVC below 70%) was 92%, and its specificity was 99%. The positive predictive value was 100%, and the negative predictive value was 98%. The Kendall correlation test revealed r = 0.99 (p < 0.0001). The t-test for paired samples revealed a negative correlation: t = −5.93 (p < 0.0001). Conclusion: The FEV1/FEV6 proved efficient for use in the diagnostic screening for COPD. There is a strong correlation between FEV1/FVC and FEV1/FEV6.

Keywords: Pulmonary disease, Chronic obstructive; Diagnosis; Spirometry; Forced expiratory volume; Vital capacity.

Objective: To investigate the level of agreement between the GINA questionnaire and the Asthma Control Test (ACT) in children and adolescents with asthma, as well as to compare the clinical, laboratory, and spirometric characteristics of patients with controlled and uncontrolled asthma as assessed by the two questionnaires. Methods: Children and adolescents with asthma had their level of asthma control cross-sectionally assessed by the GINA questionnaire and the ACT, the Childhood ACT (C-ACT) being used for the children in the sample. The participating patients also underwent spirometry, clinical assessment (for passive smoking, asthma severity, medication use, and type of inhaler device used), and laboratory measurements of vitamin D levels, blood eosinophils, and total IgE. Results: A total of 76 patients were assessed. Of those, 62% were male, and the mean age was 10 [9-12] years. In addition, 42% and 20% were classified as having uncontrolled asthma by the GINA questionnaire and the C-ACT/ACT, respectively. There was moderate agreement between the two questionnaires regarding identification of controlled and uncontrolled asthma (? = 0.505; p < 0,0001). The patients classified as having uncontrolled asthma by the GINA questionnaire had worse results in terms of daily inhaled corticosteroid dose, asthma severity, passive smoking, and spirometric parameters (FVC, FEV1, and FEF25-75%). However, there was no significant difference between patients classified as having controlled or uncontrolled asthma by the C-ACT/ACT. Conclusions: In children and adolescents with asthma, the level of agreement between the GINA questionnaire and the C-ACT/ACT appears to be moderate. The GINA questionnaire appears to have a stronger association with functional parameters, indicating better clinical assessment with less underreporting of uncontrolled asthma.

Keywords: Asthma; Pediatrics; Surveys and questionnaires; Therapeutics.