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

NCT ID: NCT00476268

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 824 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-01-31

Brief Summary

Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

beclometasone /formoterol

beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

Group Type: EXPERIMENTAL

beclomethasone/formoterol (100/6µg) pMDI

Intervention Type: DRUG

Two puffs b.i.d

Beclomethasone

Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.

Group Type: ACTIVE_COMPARATOR

Beclometasone dipropionate 250 µg/unit dose pMDI

Intervention Type: DRUG

2 inhalations bid

Formoterol powder 12 µg/unit dose

Formoterol powder 12 µg/unit dose (Foradil™)

Group Type: ACTIVE_COMPARATOR

Formoterol powder 12 µg/unit dose

Intervention Type: DRUG

2 inhalations bid

Interventions

beclomethasone/formoterol (100/6µg) pMDI

Two puffs b.i.d

Intervention Type: DRUG

Beclometasone dipropionate 250 µg/unit dose pMDI

2 inhalations bid

Intervention Type: DRUG

Formoterol powder 12 µg/unit dose

2 inhalations bid

Intervention Type: DRUG

Other Intervention Names

BecotideTM; Foradil™

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francoise Bonnet-Gonod

Role: STUDY_DIRECTOR

Chiesi Farmaceutici

References

Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.

Reference Type: RESULT

PMID: 18977646 (View on PubMed)

Other Identifiers

DM/PR/033011/003/03

Identifier Type: -

Identifier Source: org_study_id