Roflumilast Plus Montelukast in Adults With Severe Asthma

Sponsor
AstraZeneca
Study ID
NCT01765192
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast was supplied in tablets.
  • Roflumilast placebo — DRUG
    Roflumilast placebo was supplied in tablets.
  • Montelukast — DRUG
    Montelukast was supplied in tablets.

Study Details

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).

Key Dates

Start date
Feb 28, 2013
Status verified
Sep 2016
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast plus montelukast, then placebo plus montelukast
    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.
  • Experimental: Placebo plus montelukast, then roflumilast plus montelukast
    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.

Primary Outcome Measure

Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84) ]

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