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

Tracking Information

First Received Date ^ICMJE

November 17, 2003

Last Updated Date

April 2, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in lung function from baseline to final visit.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00073177 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Roflumilast

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

819

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Colombia, Mexico, Peru

Administrative Information

NCT ID ^ICMJE

NCT00073177

Responsible Party

Study ID Numbers ^ICMJE

BY217/M2-012

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Dirk Bredenbröker, MD

ALTANA Pharma, D-78467 Konstanz, Germany

Information Provided By

ALTANA Pharma

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP