Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
This study has been completed.
Sponsor:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00476268
First received: May 18, 2007
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
| Condition | Intervention | 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 |
| 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:
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: 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided by Chiesi Farmaceutici S.p.A.
Additional 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: Directorate general for the protection of Public health: Medicines 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:
|
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 22, 2013