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Keep this study
Lead
Chiesi Farmaceutici S.p.A.
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
