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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2079 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Beclometasone/formoterol (100/6 µg)

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

Group Type EXPERIMENTAL

beclometasone /formoterol

Intervention Type DRUG

BDP 100µg/FF 6µg, 1 inhalation bid

salbutamol

Ventolin : salbutamol sulphate 100 µg per metered dose

Group Type ACTIVE_COMPARATOR

Ventolin

Intervention Type DRUG

Ventolin : salbutamol sulfate 100µg

Interventions

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Ventolin

Ventolin : salbutamol sulfate 100µg

Intervention Type DRUG

beclometasone /formoterol

BDP 100µg/FF 6µg, 1 inhalation bid

Intervention Type DRUG

Other Intervention Names

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Foster

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No