PER-056-03已完成未知

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.

QUINTILES PERU S.R.L., PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,0 个研究点目标入组 0 人开始时间: 2003年10月20日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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.

•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).

发起方

QUINTILES PERU S.R.L., PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,