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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT00163527
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
• Scientific 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
• Date of first enrolment: April 2003
• Target sample size: 2054
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00163527
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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, United States

Contacts

• Name: AstraZeneca AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Roflumilast

Primary Outcome(s)

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

Secondary Outcome(s)

number of exacerbations

time to first exacerbation

change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).

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

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

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

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

Secondary ID(s)

BY217/M2-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer