Status:
COMPLETED
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (...
Eligibility Criteria
Inclusion
- Main
- Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
- Written informed consent;
- Diagnosis of asthma as defined in the GINA guidelines;
- Patients with stable asthma, according to the Investigator's opinion;
- Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
- Patients with a forced expiratory volume in one second (FEV1) \> 70% of predicted values;
- Patients with a peak inspiratory flow (PIF) \> 40 L/min
- Reversibility test;
- Non- or ex-smokers;
- A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;
- Main
Exclusion
- Pregnant or lactating female;
- Having received an investigational drug within 2 months before the screening visit
- Diagnosis of COPD as defined by the current GOLD guidelines;
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
- Known hypersensitivity to the active treatments;
- History of drug addiction or excessive use of alcohol;
- Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
- Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
- Inability to perform the required breathing technique and blood sampling;
- Lower respiratory tract infection within 1 month prior to the screening visit;
- Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01191424
Start Date
October 1 2010
End Date
September 1 2011
Last Update
July 31 2020
Active Locations (2)
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1
Copenhagen University Hospital
Copenhagen, Denmark, 2800
2
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ