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

Asthma Clinical Trial

Official title:

A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163527
• Other study ID #: BY217/M2-013
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 1, 2016
• Start date: April 2003
• Est. completion date: November 2005

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2054
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

Main 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

Main 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
Austria	ALTANA Pharma	Cities in Austria
Croatia	ALTANA Pharma	Cities in Croatia
Czech Republic	ALTANA Pharma	Cities in the Czech Repulik
Finland	ALTANA Pharma	Cities in Finland
France	ALTANA Pharma	Cities in France
Greece	ALTANA Pharma	Cities in Greece
Hungary	ALTANA Pharma	Cities in Hungary
India	ALTANA Pharma	Cities in India
Ireland	ALTANA Pharma	Cities in Ireland
Italy	ALTANA Pharma	Cities in Italy
New Zealand	ALTANA Pharma	Cities in New Zealand
Norway	ALTANA Pharma	Cities in Norway
Pakistan	ALTANA Pharma	Cities in Pakistan
Philippines	ALTANA Pharma	Cities in the Philippines
Poland	ALTANA Pharma	Cities in Poland
Portugal	ALTANA Pharma	Cities in Portugal
Russian Federation	ALTANA Pharma	Cities in the Russian Federation
Singapore	ALTANA Pharma	Sites in Singapore
South Africa	ALTANA Pharma	Cities in South Africa
Spain	ALTANA Pharma	Cities in Spain
Taiwan	ALTANA Pharma	Cities in Taiwan
Thailand	ALTANA Pharma	Cities in Thailand
United Kingdom	ALTANA Pharma	Cities in the United Kindom
United States	ALTANA Pharma	Cities in Georgia	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Croatia,  Czech Republic,  Finland,  France,  Greece,  Hungary,  India,  Ireland,  Italy,  New Zealand,  Norway,  Pakistan,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in forced expiratory volume in 1 second from baseline to final visit.
Secondary	change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
Secondary	change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
Secondary	number of rescue free/symptom free days based on the diary card
Secondary	area under the curves over the full 24-week trial period for the diary variables
Secondary	number of exacerbations
Secondary	time to first exacerbation
Secondary	change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).

External Links

•   BY217-M2-013-RDS-2008-01-21.pdf