Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862264

RA/PR/033011/005/04

2004-000718-37 (EudraCT Number)

Details and patient eligibility

About

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

Full description

The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Enrollment: 286 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
• FEV1 > or = 60% and < or = 85% of predicted normal values
• Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three 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
• Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
• Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

CHF 1535 pMDI

Experimental group

Description:

CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose

Treatment:

Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

BDP pMDI

Active Comparator group

Description:

Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose

Treatment:

Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI