Asthma
Conditions
Brief summary
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
Interventions
DRUGBeclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
DRUGBeclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
DRUGPlacebo
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient's written informed consent obtained prior to any study-related procedures. * Male or female aged between 18 and 65 years inclusive; * Evidence for partially controlled or uncontrolled asthma; * Medium daily dose of previous inhaled corticosteroids (ICS) treatment; * FEV1 between 60% and 85% of the predicted normal values; * A documented positive response to the reversibility test; * Non-smokers or ex-smokers; * A cooperative attitude and ability to be trained in the proper use of a DPI.
Exclusion criteria
* Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception. * Significant seasonal variation in asthma occurring or expected to occur during study participation; * History of near fatal asthma, brittle asthma, accident and Emergency treatment or 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; * Diagnosis of Chronic Obstructive Pulmonary Disease; * 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; * Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids; * Allergy, sensitivity or intolerance to study drugs or excipients; * Patients who received any investigational drug within the last 8 weeks before the screening; * Patients taking any of the non-permitted concomitant medication; * Subjects unlikely to comply with the study protocol; * Any clinically relevant abnormal value or physical finding at screening; * Significant medical history; * Abnormal and clinically significant 12-lead electrocardiogram; * Patients with low compliance of QVAR intake.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 Area under the curve | until 12 h post dose | FEV1= Forced expiratory volume in the first second of expiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 peak | until 12 h post dose | Maximum FEV1 value |
| FVC area under the curve | until 12 h post dose | FVC = Forced Vital Capacity |
| FVC peak | until 12 h post dose | Maximum FVC |
| Adverse events | over a period of 5 to 14 weeks | from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods. |
Countries
United Kingdom
Outcome results
None listed