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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00862264
First received: February 25, 2009
Last updated: February 14, 2012
Last verified: February 2012
  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:


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 April 17, 2014