Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Information source: Chiesi Farmaceutici S.p.A.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fixed combination Beclomethasone/formoterol HFA 134a-pMDI (Drug)
Phase: Phase 3
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
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
safety and tolerability
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.
- Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002
- FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0. 7 L
- 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.
- Pregnant or lactating females or women of childbearing potential without any efficient
- 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
Locations and Contacts
Starting date: February 2004
Last updated: May 18, 2007