CLINICAL, DOUBLE-BLIND, RANDOMIZED, CONTROLLED WITH PLACEBO, 24 WEEKS OF DURATION THAT EVALUATES THE EFFICACY AND SAFETY OF ORAL ROFLUMILAST (250 MCG OR 500 MCG) DAILY IN PATIENTS WITH ASTHMA.

Not Applicable

• Conditions: -J45; J45

• Registration Number: PER-056-03
• Lead Sponsor: QUINTILES PERU S.R.L., PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The change in forced expiratory volume of 1 second (FEVi) from Baseline to Final visit.<br>Measure:To compare the effects of oral Roflumilast QD with placebo on lung function in patients with asthma.<br>Timepoints:2 - 4 weeks<br>