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

NCT00163527 | Completed Phase 3

• 1 other identifier: BY217/M2-013
• Study Type: interventional
• Target: 2,054
• Locations: 24 countries
• Sites: 24

Brief 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.

Conditions

Asthma

Keywords

Asthma; Roflumilast; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• change in forced expiratory volume in 1 second from baseline to final visit.

Secondary Outcomes (7)

• change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow

• change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)

• number of rescue free/symptom free days based on the diary card

• area under the curves over the full 24-week trial period for the diary variables

• number of exacerbations

Interventions

Roflumilast DRUG

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Pfizer: collaborator

Study Sites (24)

ALTANA Pharma

Cities in Georgia, Georgia, United States

Location

ALTANA Pharma

Cities in Austria, Austria

Location

ALTANA Pharma

Cities in Croatia, Croatia

Location

ALTANA Pharma

Cities in the Czech Repulik, Czechia

Location

ALTANA Pharma

Cities in Finland, Finland

Location

ALTANA Pharma

Cities in France, France

Location

ALTANA Pharma

Cities in Greece, Greece

Location

ALTANA Pharma

Cities in Hungary, Hungary

Location

ALTANA Pharma

Cities in India, India

Location

ALTANA Pharma

Cities in Ireland, Ireland

Location

ALTANA Pharma

Cities in Italy, Italy

Location

ALTANA Pharma

Cities in New Zealand, New Zealand

Location

ALTANA Pharma

Cities in Norway, Norway

Location

ALTANA Pharma

Cities in Pakistan, Pakistan

Location

ALTANA Pharma

Cities in the Philippines, Philippines

Location

ALTANA Pharma

Cities in Poland, Poland

Location

ALTANA Pharma

Cities in Portugal, Portugal

Location

ALTANA Pharma

Cities in the Russian Federation, Russia

Location

ALTANA Pharma

Sites in Singapore, Singapore

Location

ALTANA Pharma

Cities in South Africa, South Africa

Location

ALTANA Pharma

Cities in Spain, Spain

Location

ALTANA Pharma

Cities in Taiwan, Taiwan

Location

ALTANA Pharma

Cities in Thailand, Thailand

Location

ALTANA Pharma

Cities in the United Kindom, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26612545 DERIVED

• 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.

  PMID: 26498386 DERIVED

Related Links

• BY217-M2-013-RDS-2008-01-21.pdf

MeSH Terms

Conditions

Asthma

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: April 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: December 2, 2016

Record last verified: 2016-09

Locations

AU (1); IN (1); GR (1); RU (1); CZ (1); HU (1); FI (1); PH (1); GB (1); FR (1); IT (1); TW (1); CR (1); IE (1); US (1); SG (1); NO (1); PA (1); ZA (1); PL (1); PT (1); ES (1); TH (1); NZ (1)