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

Condition(s) targeted: Asthma

Intervention: Fixed combination Beclomethasone/formoterol HFA 134a-pMDI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Chiesi Farmaceutici S.p.A.

Official(s) and/or principal investigator(s):
Francoise Bonnet-Gonod, Study Director, Affiliation: Chiesi Farmaceutici

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

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Pre-dose morning PEF

Secondary outcome:

Pre-dose FEV1

Other spirometric parameters

Morning and evening asthma clinical symptom scores

Percentage of night and/or days free of clinical symptoms

Use of rescue short-acting b2-agonists

Asthma exacerbations

safety and tolerability

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: February 2004
Last updated: May 18, 2007