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

December 1, 2016 updated by: AstraZeneca

A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma

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.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Drug: Roflumilast

Study Type

Interventional

Enrollment

2054

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Cities in Austria, Austria
    - ALTANA Pharma
Croatia
- - Cities in Croatia, Croatia
    - ALTANA Pharma
Czech Republic
- - Cities in the Czech Repulik, Czech Republic
    - ALTANA Pharma
Finland
- - Cities in Finland, Finland
    - ALTANA Pharma
France
- - Cities in France, France
    - ALTANA Pharma
Greece
- - Cities in Greece, Greece
    - ALTANA Pharma
Hungary
- - Cities in Hungary, Hungary
    - ALTANA Pharma
India
- - Cities in India, India
    - ALTANA Pharma
Ireland
- - Cities in Ireland, Ireland
    - ALTANA Pharma
Italy
- - Cities in Italy, Italy
    - ALTANA Pharma
New Zealand
- - Cities in New Zealand, New Zealand
    - ALTANA Pharma
Norway
- - Cities in Norway, Norway
    - ALTANA Pharma
Pakistan
- - Cities in Pakistan, Pakistan
    - ALTANA Pharma
Philippines
- - Cities in the Philippines, Philippines
    - ALTANA Pharma
Poland
- - Cities in Poland, Poland
    - ALTANA Pharma
Portugal
- - Cities in Portugal, Portugal
    - ALTANA Pharma
Russian Federation
- - Cities in the Russian Federation, Russian Federation
    - ALTANA Pharma
Singapore
- - Sites in Singapore, Singapore
    - ALTANA Pharma
South Africa
- - Cities in South Africa, South Africa
    - ALTANA Pharma
Spain
- - Cities in Spain, Spain
    - ALTANA Pharma
Taiwan
- - Cities in Taiwan, Taiwan
    - ALTANA Pharma
Thailand
- - Cities in Thailand, Thailand
    - ALTANA Pharma
United Kingdom
- - Cities in the United Kindom, United Kingdom
    - ALTANA Pharma
United States
- Georgia
  - Cities in Georgia, Georgia, United States
    - ALTANA Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

Written informed consent
Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
FEV1 between 60 and 90% predicted at visit 1
No change in asthma treatment within 4 weeks prior to visit 1

Main Exclusion Criteria:

Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
A history of lower airway infection in the four weeks prior to visit 1
A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
Patients using >8 puffs/day relief medication regularly prior to visit 1
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
Patients with chronic heart failure class III or IV (New York Heart Association)
Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
A history of alcoholism or substance abuse within the 12 months prior to visit 1
Pregnancy or women of childbearing potential who are not using a reliable method of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
number of rescue free/symptom free days based on the diary card
area under the curves over the full 24-week trial period for the diary variables
number of exacerbations
time to first exacerbation
change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

BY217-M2-013-RDS-2008-01-21.pdf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BY217/M2-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.