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
|
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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 |
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 |

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™
|
- Pre-dose morning PEF [ Time Frame: End of treatment ]
- Pre-dose FEV1 [ Time Frame: At clinic visits ]
- Other spirometric parameters [ Time Frame: At clinic visits ]
- Morning and evening asthma clinical symptom scores [ Time Frame: End of treatment ]
- Percentage of night and/or days free of clinical symptoms [ Time Frame: End of treatment ]
- Use of rescue short-acting b2-agonists [ Time Frame: End of treatment ]
- Asthma exacerbations [ Time Frame: end of treatment ]
- safety and tolerability [ Time Frame: end of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Study Director: | Francoise Bonnet-Gonod | Chiesi Farmaceutici |
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 |