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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: March 28, 2017
Last verified: March 2017
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
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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

Additional Information:
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: March 28, 2017

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

Additional relevant MeSH terms:
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017