Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00861926

Collaborator

(none)

2,079

Enrollment

Location

Arms

Duration (Months)

83.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Ventolin Drug: beclometasone /formoterol	Phase 3

Detailed Description

To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics

Study Design

Study Type:

Interventional

Actual Enrollment :

2079 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

48-week,Multinational,Randomized,Double-blind,2-parallel Groups,Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics >=18 Years of Age

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beclometasone/formoterol (100/6 µg) Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator	Drug: beclometasone /formoterol BDP 100µg/FF 6µg, 1 inhalation bid Other Names: Foster
Active Comparator: salbutamol Ventolin : salbutamol sulphate 100 µg per metered dose	Drug: Ventolin Ventolin : salbutamol sulfate 100µg

Arm

Intervention/Treatment

Experimental: Beclometasone/formoterol (100/6 µg)

Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator

Drug: beclometasone /formoterol

BDP 100µg/FF 6µg, 1 inhalation bid

Other Names:

Foster

Active Comparator: salbutamol

Ventolin : salbutamol sulphate 100 µg per metered dose

Drug: Ventolin

Ventolin : salbutamol sulfate 100µg

Outcome Measures

Primary Outcome Measures

Time to first severe asthma exacerbation [At each clinic visit]

Secondary Outcome Measures

Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs [At each clinic visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written signed and dated informed consent obtained.
Male or female patients aged ≥ 18 years.
A positive reversibility test
Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)
Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit
Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit
Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value.
Non smokers or ex-smokers

Exclusion Criteria:

Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of acceptable methods of contraception
Body Mass Index (BMI) > 34 kg/m2.
Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.
Use of systemic steroids in the last month.
Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.
Clinically relevant laboratory abnormalities
Patients who have an abnormal QTcF interval value
Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.
Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
Patients being treated with anti-IgE antibodies.
Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit
Severe asthma exacerbation in the last month before screening visit