- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00861926
Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics
March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.
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
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
2079
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ferrara, Italy
- Pr Papi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
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BDP 100µg/FF 6µg, 1 inhalation bid
Other Names:
|
Active Comparator: salbutamol
Ventolin : salbutamol sulphate 100 µg per metered dose
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Ventolin : salbutamol sulfate 100µg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first severe asthma exacerbation
Time Frame: At each clinic visit
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At each clinic visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs
Time Frame: At each clinic visit
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At each clinic visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alberto Papi, Professor, Università degli Studi di Ferrara
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Papi A, Corradi M, Pigeon-Francisco C, Baronio R, Siergiejko Z, Petruzzelli S, Fabbri LM, Rabe KF. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Mar;1(1):23-31. doi: 10.1016/S2213-2600(13)70012-2. Epub 2013 Mar 4.
- Morjaria JB, Rigby AS, Morice AH. Symptoms and exacerbations in asthma: an apparent paradox? Ther Adv Chronic Dis. 2019 Oct 24;10:2040622319884387. doi: 10.1177/2040622319884387. eCollection 2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
March 13, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Beclomethasone
- Formoterol Fumarate
Other Study ID Numbers
- CCD-0804-PR-0034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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