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

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A. Identifier:
First received: March 13, 2009
Last updated: February 14, 2012
Last verified: February 2012
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

Condition Intervention Phase
Drug: Ventolin
Drug: beclometasone /formoterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Time to first severe asthma exacerbation [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]

Enrollment: 2079
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Foster
Active Comparator: salbutamol
Ventolin : salbutamol sulphate 100 µg per metered dose
Drug: Ventolin
Ventolin : salbutamol sulfate 100µg

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00861926

Pr Papi
Ferrara, Italy
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Alberto Papi, Professor Universita degli Studi di Ferrara
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT00861926     History of Changes
Other Study ID Numbers: CCD-0804-PR-0034 
Study First Received: March 13, 2009
Last Updated: February 14, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency ;Croatia: Agency for Medicinal Product and Medical Devices;
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Authority for Scientific Research
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Ministry of Health
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory

Keywords provided by Chiesi Farmaceutici S.p.A.:
Maintenance and Reliever Treatments

Additional relevant MeSH terms:
Formoterol Fumarate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Tocolytic Agents processed this record on May 26, 2016