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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: beclomethasone/formoterol (100/6µg) pMDI; Drug: Formoterol powder 12 µg/unit dose; Drug: Beclometasone dipropionate 250 µg/unit dose pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00476268

DM/PR/033011/003/03

Details and patient eligibility

About

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

Full 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.

Enrollment: 824 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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824 participants in 3 patient groups

beclometasone /formoterol

Experimental group

Description:

beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

Treatment:

Drug: beclomethasone/formoterol (100/6µg) pMDI

Beclomethasone

Active Comparator group

Description:

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

Treatment:

Drug: Beclometasone dipropionate 250 µg/unit dose pMDI

Formoterol powder 12 µg/unit dose

Active Comparator group

Description:

Formoterol powder 12 µg/unit dose (Foradil™)

Treatment:

Drug: Formoterol powder 12 µg/unit dose