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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00861926
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Ventolin Drug: beclometasone /formoterol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2079 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to first severe asthma exacerbation [ Time Frame: At each clinic visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00861926

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

Additional Information:
Publications of Results:
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Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT00861926     History of Changes
Other Study ID Numbers: CCD-0804-PR-0034
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Keywords provided by Chiesi Farmaceutici S.p.A.:
Maintenance and Reliever Treatments
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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