None listed
Conditions
Interventions
Roflumilast 250 mg Type of group
Roflumilast 250 mg will be given for 24 weeks.
Group name:placebo Type of group
Roflumilast placebo will be administered for 24 weeks.
Sponsors
QUINTILES PERU S.R.L., PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women from 18 to 70 years of age. 2. Patients must have received verbal and written information about the study, all questions must be answered satisfactorily and the informed consent must be signed and dated by the patient and the researcher / group designated for the study. 3. The patient should have a diagnosis of persistent bronchial asthma. 4. The patient should have a FEVi between 60 and 90% of the calculated at visit 1 when the albuterol / salbutamol (rescue medication) is removed, at least 4 hours before the measurement. 5. A change in asthma treatment has not occurred within 4 weeks prior to visit 1. 6. The patient is non-smoker or ex-smoker. 7. Respect of the investigator, the patient is fit and wants to comply with the visits of this study, the procedures (which include pulmonary function test, laboratory analysis), and complete correctly and in time with the electronic study journal per day.
Exclusion criteria
Exclusion criteria: 1. Patients with poorly controlled asthma is defined as that which requires the use of oral or parenteral corticosteroids, admission to a hospital for the treatment of asthma (including treatment in an emergency room or emergency medical center), or the exacerbation of asthma in the 4 weeks prior to visit 1. 2. Patients suffering from seasonal asthma or patients who have severe exacerbations of asthma due to effects of the seasons during the course of the study or the period of treatment. 3. History of lower airway infection (treated with antibiotic) in the 4 weeks prior to visit 1. 4. Diagnosis of chronic obstructive pulmonary disease (COPD) and / or other relevant lung diseases. 5. Patients who are using short-acting bronchodilators (beta-agonist)> 8 shots / day (more than 3 days per week on average) prior to visit 1. 6. Clinically relevant abnormal laboratory values ​​suggesting an undiagnosed disease requiring further clinical evaluation (evaluated by the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change in forced expiratory volume of 1 second (FEVi) from Baseline to Final visit. Measure:To compare the effects of oral Roflumilast QD with placebo on lung function in patients with asthma. Timepoints:2 - 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Change from the baseline visit and at each visit of the spirometric variables; forced vital capacity (FVC), mean expiratory flow (FEF25.75), peak expiratory flow (PEF), FEVi / FVC and FEVj (except in the final visit). • Change from the baseline visit and at each visit, of the spirometric variables FEVi, forced vital capacity (FVC), average expiratory flow (FEF25.75), and FEVj / FVC. • Changes from the Baseline visit and each visit based on the variables of the daily data (PEFam, PEFpm, PEF daytime variability, FEViam, FEVipm, asthma symptom score [during the day, during the night and in total], and the use of rescue medication). • Daily AUCs data in the 24 weeks of study. • Numbers of free days of rescue / symptoms of free days based on the electronic diary. • Number of exacerbations (mild or severe). • Number of exacerbations (severe) • Time in days until the first exacerbation (mild or severe) • Time in days until the first exacerbation (severe). Measure:To assess the effects of Roflumilast on asthma symptoms including peak respiratory flow in the morning and in the afternoon, asthma symptom severity score, and the use of supplemental short-acting beta-agonist as recorded in the electronic diaries, the number of exacerbations, health outcomes and quality of life. Timepoints:2 - 4 semanas | — |
Countries
Argentina, Colombia, Mexico, Peru
Outcome results
None listed