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

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ClinicalTrials.gov Identifier: NCT00476268
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 3, 2012
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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Brief Summary:
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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™


Outcome Measures
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Primary Outcome Measures :
  1. Pre-dose morning PEF [ Time Frame: End of treatment ]

Secondary Outcome Measures :
  1. Pre-dose FEV1 [ Time Frame: At clinic visits ]
  2. Other spirometric parameters [ Time Frame: At clinic visits ]
  3. Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ]
  4. Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ]
  5. Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ]
  6. Asthma exacerbations [ Time Frame: end of treatment ]
  7. safety and tolerability [ Time Frame: end of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476268


Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Study Director: Francoise Bonnet-Gonod Chiesi Farmaceutici
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists