Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: beclomethasone/formoterol (100/6µg) pMDI (Drug); Beclometasone dipropionate 250 µg/unit dose pMDI (Drug); Formoterol powder 12 µg/unit dose (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
Summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with
moderate to severe persistent asthma.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pre-dose morning PEF
Secondary outcome: Pre-dose FEV1Other 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.
Eligibility
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
Locations and Contacts
Additional Information
Starting date: February 2004
Last updated: April 2, 2012
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