A 48-week Study Comparing the Efficacy of Foster for Maintenance and Reliever Versus Foster for Maintenance + Salbutamol as Reliever in Asthmatics
Information source: Chiesi Farmaceutici S.p.A.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Foster (Drug); Ventolin (Drug)
Phase: Phase 3
Status: Recruiting
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
Overall contact:
Martine Cartier, Phone: +33147684358, Email: m.cartier@chiesifrance.com
Summary
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study
Clinical Details
Official title: A 48-week, Multicentre, Multinational, Randomized, Double-blind, 2-arm Parallel Group, Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics > or = 18 Years of Age
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Martine Cartier, Phone: +33147684358, Email: m.cartier@chiesifrance.com
Pr Papi, Ferrara, Italy; Recruiting
Papi, Prof, Phone: +390532236111, Email: ppa@unife.it
Additional Information
Starting date: March 2009
Ending date: February 2011
Last updated: September 3, 2009
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