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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014