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

Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Ventolin (Drug); beclometasone /formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Chiesi Farmaceutici S.p.A.

Official(s) and/or principal investigator(s):
Alberto Papi, Professor, Principal Investigator, Affiliation: Universita degli Studi di Ferrara


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome: Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Patients being treated with anti-IgE antibodies.

- Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening


- Severe asthma exacerbation in the last month before screening visit

Locations and Contacts

Pr Papi, Ferrara, Italy
Additional Information

Starting date: March 2009
Last updated: February 14, 2012

Page last updated: August 23, 2015

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