Overview
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Status:
Completed
Completed
Trial end date:
2005-01-01
2005-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chiesi Farmaceutici S.p.A.Treatments:
Beclomethasone
Formoterol Fumarate
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