Clinical trial NCT00163527: Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Roflumilast
Corticosteroids
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-09-14
Enrollment: 2054
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: change in forced expiratory volume in 1 second from baseline to final visit.
Secondary outcomes:
measure: change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
measure: change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
measure: number of rescue free/symptom free days based on the diary card
measure: area under the curves over the full 24-week trial period for the diary variables
measure: number of exacerbations
measure: time to first exacerbation
measure: change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
Other outcomes:
Locations:
city: Cities in Georgia
country: United States
facility: ALTANA Pharma
state: Georgia
city: Cities in Austria
country: Austria
facility: ALTANA Pharma
city: Cities in Croatia
country: Croatia
facility: ALTANA Pharma
city: Cities in the Czech Repulik
country: Czech Republic
facility: ALTANA Pharma
city: Cities in Finland
country: Finland
facility: ALTANA Pharma
city: Cities in France
country: France
facility: ALTANA Pharma
city: Cities in Greece
country: Greece
facility: ALTANA Pharma
city: Cities in Hungary
country: Hungary
facility: ALTANA Pharma
city: Cities in India
country: India
facility: ALTANA Pharma
city: Cities in Ireland
country: Ireland
facility: ALTANA Pharma
city: Cities in Italy
country: Italy
facility: ALTANA Pharma
city: Cities in New Zealand
country: New Zealand
facility: ALTANA Pharma
city: Cities in Norway
country: Norway
facility: ALTANA Pharma
city: Cities in Pakistan
country: Pakistan
facility: ALTANA Pharma
city: Cities in the Philippines
country: Philippines
facility: ALTANA Pharma
city: Cities in Poland
country: Poland
facility: ALTANA Pharma
city: Cities in Portugal
country: Portugal
facility: ALTANA Pharma
city: Cities in the Russian Federation
country: Russian Federation
facility: ALTANA Pharma
city: Sites in Singapore
country: Singapore
facility: ALTANA Pharma
city: Cities in South Africa
country: South Africa
facility: ALTANA Pharma
city: Cities in Spain
country: Spain
facility: ALTANA Pharma
city: Cities in Taiwan
country: Taiwan
facility: ALTANA Pharma
city: Cities in Thailand
country: Thailand
facility: ALTANA Pharma
city: Cities in the United Kindom
country: United Kingdom
facility: ALTANA Pharma
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.