A 48-week Study Comparing the Efficacy of Foster for Maintenance and Reliever Versus Foster for Maintenance + Salbutamol as Reliever in Asthmatics - Full Text View

Sponsor:	Chiesi Farmaceutici S.p.A.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00861926

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Foster Drug: Ventolin	Phase III

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:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

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 ]

Estimated Enrollment:	2400
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: 1 Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator	Drug: Foster Foster : BDP/Formoterol 100/6 µg
Active Comparator: 2 Ventolin : salbutamol sulphate 100 µg per metered dose	Drug: Ventolin Ventolin : salbutamol

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861926

Locations

Italy
Pr Papi
Ferrara, Italy

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator:

Alberto Papi, Professor

Universita degli Studi di Ferrara

More Information

No publications provided

Responsible Party:	Coordinating Investigator - Pr Papi, Universita degli Studi di Ferrara
ClinicalTrials.gov Identifier:	NCT00861926 History of Changes
Other Study ID Numbers:	CCD-0804-PR-0034
Study First Received:	March 13, 2009
Last Updated:	April 12, 2011
Health Authority:	Bulgaria: Bulgarian Drug Agency ;Croatia: Agency for Medicinal Product and Medical Devices;; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; 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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012