Clinical trial NCT00476268: Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pre-dose morning PEF
timeFrame: End of treatment
Secondary outcomes:
measure: Pre-dose FEV1
timeFrame: At clinic visits
measure: Other spirometric parameters
timeFrame: At clinic visits
measure: Morning and evening asthma clinical symptom scores
timeFrame: End of treatment
measure: Percentage of night and/or days free of clinical symptoms
timeFrame: End of treatment
measure: Use of rescue short-acting b2-agonists
timeFrame: End of treatment
measure: Asthma exacerbations
timeFrame: end of treatment
measure: safety and tolerability
timeFrame: end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Chiesi Farmaceutici
name: Francoise Bonnet-Gonod
role: STUDY_DIRECTOR
References:
citation: 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.