Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

Part of paid clinical trials in Cities in Georgia, Georgia.

Sponsor
AstraZeneca
Study ID
NCT00163527
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Key Dates

Start date
Apr 30, 2003
Status verified
Sep 2016
Primary completion
Nov 30, 2005
Completion
Nov 30, 2005

Study Design

Enrollment
2,054 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

change in forced expiratory volume in 1 second from baseline to final visit.

Locations (1)

FacilityCityStateZIPSite coordinators
ALTANA PharmaCities in GeorgiaGeorgia--

Find similar trials in Cities in Georgia, GA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
ALTANA Pharma· Cities in Georgia, GA

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