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Keep this study
Lead
Chiesi Farmaceutici S.p.A.
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of COPD (according to GOLD guidelines)
FEV1 \> or equal 30% and \< 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
COPD symptoms for at least 2 years
At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year
You may not be if
Current or past diagnosis of asthma, or any evidence suggestive of asthma
Positive FEV1 reversibility test
Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
Long term oxygen therapy
Clareo Health | Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
