asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Foster® NEXThaler®
Product Code: CHF 1535 NEXThaler® BDP 100 µg / FF 6 µg
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: beclometasone dipropionate
CAS Number: 5534-09-8
Other
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient's written informed consent obtained prior to any study-related procedures. 2. Male or female aged between 18 and 65 years inclusive; 3. Evidence for "partially controlled" or "uncontrolled" asthma; 4. Medium daily dose of previous inhaled corticosteroids (ICS) treatment; 5. FEV1 between 60% and 85% of the predicted normal values; 6. A documented positive response to the reversibility test; 7. Non-smokers or ex-smokers; 8. A cooperative attitude and ability to be trained in the proper use of a DPI. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception. 2. Significant seasonal variation in asthma occurring or expected to occur during study participation; 3. 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; 4. Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening; 5. Diagnosis of Chronic Obstructive Pulmonary Disease; 6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency; 7. Diagnosis of restrictive lung disease; 8. Patients treated with oral or parenteral corticosteroids in the previous 8 weeks; 9. Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids; 10. Allergy, sensitivity or intolerance to study drugs or excipients; 11. Patients who received any investigational drug within the last 8 weeks before the screening; 12. Patients taking any of the non-permitted concomitant medication; 13. Subjects unlikely to comply with the study protocol; 14. Any clinically relevant abnormal value or physical finding at screening; 15. Significant medical history; 16. Abnormal and clinically significant 12-lead electrocardiogram; 17. Patients with low compliance of QVAR intake.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority in terms of acute bronchodilator effect (FEV1 AUC0-12h) 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 (4 and 1 inhalations) in partially controlled and uncontrolled adult asthmatic patients.;Secondary Objective: • To evaluate the efficacy of the two strengths on pulmonary function in terms of FVC (peak and AUC0-12h) and FEV1 other parameters (peak, AUC0-4h and AUC4-12h); • To evaluate the safety profile in terms of adverse events (AEs) and adverse drug reactions (ADRs).;Primary end point(s): FEV1 area under the curve (AUC) over 12 hours post dose standardised by time (AUC0-12h, L);Timepoint(s) of evaluation of this end point: FEV1 taken at pre-dose within 60 min of the dose and at 10 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 12 hours post-dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - FEV1 AUC0-4h standardised by time (L) and FEV1 AUC4-12h standardised by time (L); - Peak FEV1 (L) in terms of absolute value; - FVC AUC0-12h standardised by time (L) and peak (L). - Adverse events and adverse drug reactions; ;Timepoint(s) of evaluation of this end point: FEV1 and FVC at pre-dose within 60 min of the dose and at 10 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 12 hours postdose) Adverse events and adverse drug reactions will be evaluated throughout the whole study from screening until follow-up. | — |
Countries
United Kingdom
Contacts
Public ContactSara Collarini
Chiesi Farmaceutici S.p.A.
Outcome results
None listed