Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

October 24, 2016 updated by: AstraZeneca

A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma

The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

819

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

  • Argentina
      • Cities in Argentina, Argentina
        • ALTANA Pharma
  • Colombia
      • Cities in Colombia, Colombia
        • ALTANA Pharma
  • Mexico
      • Cities in Mexico, Mexico
        • ALTANA Pharma
  • Peru
      • Cities in Peru, Peru
        • ALTANA Pharma
  • United States
    • Alabama
      • Cities in Alabama, Alabama, United States
        • ALTANA Pharma
    • Arizona
      • Cities in Arizona, Arizona, United States
        • ALTANA Pharma
    • Arkansas
      • Cities in Arkansas, Arkansas, United States
        • ALTANA Pharma
    • California
      • Cities in California, California, United States
        • ALTANA Pharma
    • Colorado
      • Cities in Colorado, Colorado, United States
        • ALTANA Pharma
    • Florida
      • Cities in Florida, Florida, United States
        • ALTANA Pharma
    • Georgia
      • Cities in Georgia, Georgia, United States
        • ALTANA Pharma
    • Idaho
      • Cities in Idaho, Idaho, United States
        • ALTANA Pharma
    • Illinois
      • Cities in Illinois, Illinois, United States
        • ALTANA Pharma
    • Indiana
      • Cities in Indiana, Indiana, United States
        • ALTANA Pharma
    • Iowa
      • Cities in Iowa, Iowa, United States
        • ALTANA Pharma
    • Kansas
      • Cities in Kansas, Kansas, United States
        • ALTANA Pharma
    • Kentucky
      • Cities in Kentucky, Kentucky, United States
        • ALTANA Pharma
    • Louisiana
      • Cities in Louisiana, Louisiana, United States
        • ALTANA Pharma
    • Maryland
      • Cities in Maryland, Maryland, United States
        • ALTANA Pharma
    • Massachusetts
      • Massachusetts, Massachusetts, United States
        • ALTANA Pharma
    • Michigan
      • Cities in Michigan, Michigan, United States
        • ALTANA Pharma
    • Minnesota
      • Cities in Minnesota, Minnesota, United States
        • ALTANA Pharma
    • Mississippi
      • Cities in Mississippi, Mississippi, United States
        • ALTANA Pharma
    • Missouri
      • Cities in Missouri, Missouri, United States
        • ALTANA Pharma
    • Montana
      • Cities in Montana, Montana, United States
        • ALTANA Pharma
    • Nebraska
      • Cities in Nebraska, Nebraska, United States
        • ALTANA Pharma
    • Nevada
      • Cities in Nevada, Nevada, United States
        • ALTANA Pharma
    • New Jersey
      • Cities in New Jersey, New Jersey, United States
        • ALTANA Pharma
    • New York
      • Cities in New York, New York, United States
        • ALTANA Pharma
    • North Carolina
      • Cities in North Carolina, North Carolina, United States
        • ALTANA Pharma
    • North Dakota
      • Cities in North Dakota, North Dakota, United States
        • ALTANA Pharma
    • Oregon
      • Cities in Oregon, Oregon, United States
        • ALTANA Pharma
    • Pennsylvania
      • Cities in Pennsylvania, Pennsylvania, United States
        • ALTANA Pharma
    • Rhode Island
      • Cities in Rhode Island, Rhode Island, United States
        • ALTANA Pharma
    • South Carolina
      • Cities in South Carolina, South Carolina, United States
        • ALTANA Pharma
    • Tennessee
      • Cities in Tennessee, Tennessee, United States
        • ALTANA Pharma
    • Texas
      • Cities in Texas, Texas, United States
        • ALTANA Pharma
    • Utah
      • Cities in Utah, Utah, United States
        • ALTANA Pharma
    • Virginia
      • Cities in Virginia, Virginia, United States
        • ALTANA Pharma
    • Washington
      • Cities in Washington, Washington, United States
        • ALTANA Pharma
    • Wisconsin
      • Cities in Wisconsin, Wisconsin, 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Persistent bronchial asthma
  • No change in asthma treatment within 4 weeks prior to visit 1
  • Non-smoker or ex-smoker (for 12 months or longer)

Main Exclusion Criteria:

  • Poorly controlled asthma or seasonal asthma
  • History of lower airway infection four weeks prior to visit 1
  • Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
  • Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
  • Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
  • Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
  • Patients with chronic heart failure
  • Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
  • Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
  • Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study

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 lung function from baseline to final visit.

Secondary Outcome Measures

Outcome Measure
safety.
time to first exacerbation
pulmonary function variables
quality of life variables
diary variables
number of asthma exacerbations

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

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

November 1, 2003

Study Registration Dates

First Submitted

November 17, 2003

First Submitted That Met QC Criteria

November 18, 2003

First Posted (Estimate)

November 19, 2003

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-012

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.

Clinical Trials on Asthma

Clinical Trials on Roflumilast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe