Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Study Identifier:
DM/PR/033011/003/03
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: beclomethasone/formoterol (100/6µg) pMDI
- Drug: Beclometasone dipropionate 250 µg/unit dose pMDI
- Drug: Formoterol powder 12 µg/unit dose
Date
Feb 2004 - Jan 2005
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 70 Years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No
Protocol Summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
Study Locations
No locations found.