Asthma
Conditions
Brief summary
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
Detailed description
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.
Interventions
DRUGFixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines) * FEV1 \> or = 60% and \< or = 85% of predicted normal values * Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three 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 * Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities * Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability \> or = 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-dose morning PEF | At the end of treatment after 3 month of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of night and/or days free of clinical symptoms | End of treatment after 3 month of treatment |
| Morning and evening asthma clinical symptom scores | End of treatment after 3 month of treatment |
| Pre-dose FEV1 - Other spirometric parameters - | Every 6 weeks |
| Asthma exacerbations | Every 6 weeks |
| Safety and Tolerability | Every 6 weeks |
| Use of rescue short-acting b2-agonists | End of treatment after 3 month of treatment |
Outcome results
None listed