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

NCT ID: NCT00163527

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2054 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Roflumilast Corticosteroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Roflumilast

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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ALTANA Pharma

Cities in Georgia, Georgia, United States

Site Status

ALTANA Pharma

Cities in Austria, , Austria

Site Status

ALTANA Pharma

Cities in Croatia, , Croatia

Site Status

ALTANA Pharma

Cities in the Czech Repulik, , Czechia

Site Status

ALTANA Pharma

Cities in Finland, , Finland

Site Status

ALTANA Pharma

Cities in France, , France

Site Status

ALTANA Pharma

Cities in Greece, , Greece

Site Status

ALTANA Pharma

Cities in Hungary, , Hungary

Site Status

ALTANA Pharma

Cities in India, , India

Site Status

ALTANA Pharma

Cities in Ireland, , Ireland

Site Status

ALTANA Pharma

Cities in Italy, , Italy

Site Status

ALTANA Pharma

Cities in New Zealand, , New Zealand

Site Status

ALTANA Pharma

Cities in Norway, , Norway

Site Status

ALTANA Pharma

Cities in Pakistan, , Pakistan

Site Status

ALTANA Pharma

Cities in the Philippines, , Philippines

Site Status

ALTANA Pharma

Cities in Poland, , Poland

Site Status

ALTANA Pharma

Cities in Portugal, , Portugal

Site Status

ALTANA Pharma

Cities in the Russian Federation, , Russia

Site Status

ALTANA Pharma

Sites in Singapore, , Singapore

Site Status

ALTANA Pharma

Cities in South Africa, , South Africa

Site Status

ALTANA Pharma

Cities in Spain, , Spain

Site Status

ALTANA Pharma

Cities in Taiwan, , Taiwan

Site Status

ALTANA Pharma

Cities in Thailand, , Thailand

Site Status

ALTANA Pharma

Cities in the United Kindom, , United Kingdom

Site Status

Countries

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United States Austria Croatia Czechia Finland France Greece Hungary India Ireland Italy New Zealand Norway Pakistan Philippines Poland Portugal Russia Singapore South Africa Spain Taiwan Thailand United Kingdom

References

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Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.

Reference Type DERIVED
PMID: 26612545 (View on PubMed)

Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.

Reference Type DERIVED
PMID: 26498386 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4472&filename=BY217-M2-013-RDS-2008-01-21.pdf

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

Other Identifiers

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BY217/M2-013

Identifier Type: -

Identifier Source: org_study_id