Conditions: Asthma
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 64
Healthy volunteers: no

Brief summary:
This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).

Detailed description:
The drug being tested in this study is called roflumilast. Roflumilast is being tested to treat people who have asthma. This study will look at lung function and asthma symptoms of people who take roflumilast in combination with montelukast.

Arms:
arm 1: Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks. arm 2: Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.

Interventions: intervention 1: Roflumilast intervention 2: Roflumilast placebo intervention 3: Montelukast
Intervention descriptions: intervention 1: Roflumilast was supplied in tablets. intervention 2: Roflumilast placebo was supplied in tablets. intervention 3: Montelukast was supplied in tablets.

Protocol document: