Long-Term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

This study has been completed.

First Received: October 31, 2005 Last Updated: December 12, 2008 History of Changes

Sponsors and Collaborators:	ALTANA Pharma Mitsubishi Tanabe Pharma Corporation
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00246922

Purpose

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Condition	Intervention	Phase
Bronchial Asthma	Drug: Roflumilast	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Long-Term Study of APTA-2217 in Adult Patients With Bronchial 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:

Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .

Secondary Outcome Measures:

Efficacy.

Estimated Enrollment:	150
Study Start Date:	December 2004
Study Completion Date:	October 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years to 71 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main inclusion criteria:

Patients with asthma disease
Written informed consent
Patients who completed the 24-week evaluation of study APTA-2217-05

Main exclusion criteria:

% FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
Serious diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246922

Locations

Japan
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan

Sponsors and Collaborators

ALTANA Pharma

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Chair:

Gerhard Cullmann

Nycomed, 78467 Konstanz, Germany

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed GmbH )
Study ID Numbers:	APTA-2217-07
Study First Received:	October 31, 2005
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00246922 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by ALTANA Pharma:

Asthma
Roflumilast
phosphodiesterase 4 inhibitor

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 10, 2009