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

Chiesi

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: beclometasone /formoterol

Drug: Ventolin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00861926

CCD-0804-PR-0034

Details and patient eligibility

About

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

Full description

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

Enrollment

2,079 patients

Sex

All

Ages

18+ years old

Volunteers

No 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