Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
First received: May 18, 2007
Last updated: April 2, 2012
Last verified: April 2012
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

Condition Intervention Phase
Drug: beclomethasone/formoterol (100/6µg) pMDI
Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
Drug: Formoterol powder 12 µg/unit dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe 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: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-dose FEV1 [ Time Frame: At clinic visits ] [ Designated as safety issue: No ]
  • Other spirometric parameters [ Time Frame: At clinic visits ] [ Designated as safety issue: No ]
  • Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Asthma exacerbations [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 824
Study Start Date: February 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: beclometasone /formoterol
beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI
Drug: beclomethasone/formoterol (100/6µg) pMDI
Two puffs b.i.d
Active Comparator: Beclomethasone
Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.
Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
2 inhalations bid
Other Name: BecotideTM
Active Comparator: Formoterol powder 12 µg/unit dose
Formoterol powder 12 µg/unit dose (Foradil™)
Drug: Formoterol powder 12 µg/unit dose
2 inhalations bid
Other Name: Foradil™

Detailed Description:
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.

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

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)
  • FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
  • Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:

    750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)

  • Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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.
  • Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
  • Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.
  • Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability > 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476268

Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Study Director: Francoise Bonnet-Gonod Chiesi Farmaceutici
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00476268     History of Changes
Other Study ID Numbers: DM/PR/033011/003/03 
Study First Received: May 18, 2007
Last Updated: April 2, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Formoterol Fumarate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 25, 2016