Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Phase 2
Completed
- Conditions
- Asthma
- Interventions
- Drug: Foster BDP/FormoterolDrug: CHF 1535 Next DPIDrug: Placebo
- Registration Number
- NCT00868023
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Foster BDP/Formoterol CHF 1535 pMDI HFA : BDP/Formo 400/24 µg 3 CHF 1535 Next DPI CHF 1535 DPI : BDP/Formo 100/6 µg 1 CHF 1535 Next DPI CHF 1535 DPI : BDP/Formo 400/24 µg 5 Placebo Placebo 4 Foster BDP/Formoterol CHF 1535 pMDI HFA : BDP/Formo 100/6 µg
- Primary Outcome Measures
Name Time Method FEV1 AUC0-12h Every week
- Secondary Outcome Measures
Name Time Method FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation Every week
Trial Locations
- Locations (1)
Pr DS SINGH
🇬🇧Manchester, United Kingdom