Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma - Full Text View

Purpose

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

Condition	Intervention	Phase
Asthma	Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Beclomethasone dipropionate Formoterol fumarate Formoterol Beclomethasone dipropionate monohydrate Arformoterol Tartrate

U.S. FDA Resources

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

Primary Outcome Measures:

Pre-dose morning PEF [ Time Frame: At the end of treatment after 3 month of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pre-dose FEV1 - Other spirometric parameters - [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment after 3 month of treatment ] [ Designated as safety issue: No ]
Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment after 3 month of treatment ] [ Designated as safety issue: No ]
Use of rescue short-acting b2-agonists [ Time Frame: End of treatment after 3 month of treatment ] [ Designated as safety issue: No ]
Asthma exacerbations [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	286
Study Start Date:	August 2004
Study Completion Date:	September 2005

Arms	Assigned Interventions
Experimental: CHF 1535 pMDI CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose	Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Active Comparator: BDP pMDI Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose	Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

Detailed Description:

The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
FEV1 > or = 60% and < or = 85% of predicted normal values
Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
A documented positive response to the reversibility test

Exclusion Criteria:

Pregnant or lactating females or women of childbearing potential without any efficient contraception
Heavy smokers defined as smoking for > 10 pack years
Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862264

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Study Director:

Françoise Bonnet Gonod

Chiesi Farmaceutici

More Information

No publications provided

Responsible Party:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00862264 History of Changes
Other Study ID Numbers:	RA/PR/033011/005/04
Study First Received:	February 25, 2009
Last Updated:	February 14, 2012
Health Authority:	Poland: Ministry of Health Romania: National Medicines Agency Hungary: National Institute of Pharmacy Bulgaria: Bulgarian Drug Agency Slovakia: State Institute for Drug Control Singapore: Health Sciences Authority Malaysia: Ministry of Health South Africa: Department of Health

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013