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

This study has been completed.

First Received on November 17, 2003. Last Updated on January 18, 2012 History of Changes

Sponsor:	ALTANA Pharma
Information provided by (Responsible Party):	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00073177

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Roflumilast	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Roflumilast

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	819
Study Start Date:	November 2003

Eligibility

Criteria

Main Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073177

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Director:

Dirk Bredenbröker, MD

ALTANA Pharma, D-78467 Konstanz, Germany

More Information

No publications provided

Responsible Party:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00073177 History of Changes
Other Study ID Numbers:	BY217/M2-012
Study First Received:	November 17, 2003
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012