Asthma
Conditions
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
Interventions
DRUGCHF 1535 Next DPI
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
DRUGPlacebo
Placebo
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 AUC0-12h | Every week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed