Status:
COMPLETED
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
Detailed Description
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients
Eligibility Criteria
Inclusion
- Patient's written informed consent obtained prior to any study-related procedures.
- Outpatient male or female aged ≥ 18 years.
- Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
- Under previous inhaled corticosteroids (ICS) treatment at the screening visit
- Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
- A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
- Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
- Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
- Non-smokers or ex-smokers
Exclusion
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
- Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
- History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
- Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
- Diagnosis of restrictive lung disease.
- Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- Allergy, sensitivity or intolerance to study drugs or excipients.
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00868023
Start Date
February 1 2009
End Date
October 1 2009
Last Update
March 30 2017
Active Locations (1)
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1
Pr DS SINGH
Manchester, United Kingdom, M23 9QZ