Asthma MedDRA version: 19.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Fostair NEXThaler 100/6
Product Code: CHF1535 100/6 µg NEXThaler®
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Current Spons
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient's written informed consent obtained prior to any study-related procedure; - Male or female aged between 18 and 60 years inclusive; - Ability to understand the study procedures and to be trained to use the inhalers correctly; - Non- or ex-smokers who smoked =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Clinically relevant and uncontrolled concomitant diseases or disorders that may interfere with successful completion of this protocol in the investigator's opinion; - Any clinically relevant abnormal laboratory value suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment; - History of unstable cardiac disease, myocardial infarction or stroke within 3 months prior to screening; - Patients with known aortic aneurism; - Uncontrolled hypertension or clinically relevant abnormal pulse rate; - Abnormal and clinically relevant 12-lead electrocardiogram (ECG); - Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation or the subject is expected to take non-permitted concomitant medications during the study; - Occurrence of asthma exacerbation or respiratory tract infection within 4 weeks before screening or prior to randomization; - Significant seasonal variation in asthma, expected during study participation; - History of near fatal asthma or of past hospitalisation for asthma in Intensive Care unit; - Diagnosis of Chronic Obstructive Lung Disease (COPD), history of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, diagnosis of restrictive lung disease; - History of hypersensitivity to any of the excipients contained in the formulation used for drug administration and for other procedures in the trial; - Acute bronchoconstriction induced by methacholine challenge test at screening not well controlled with SABA according to investigator's opinion; - Heavy caffeine drinker; - Documented history of alcohol and/or drug abuse within 12 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of CHF1535 100/6 µg NEXThaler® versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function [change in FEV1 (L) from baseline, i.e. post-diluent, to 5 min after study drug inhalation] in asthmatic patients on low-medium doses of ICS or ICS plus LABA fixed or free combination.;Secondary Objective: To evaluate the effect of the treatments on additional FEV1 variables and time points and clinical outcome measures.;Primary end point(s): Change in FEV1 (L) from baseline to 5 min after study drug inhalation.;Timepoint(s) of evaluation of this end point: 5 minutes after study drug inhalation as reliever therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change in FEV1 (L) from post-diluent at 1, 10, 20 and 30 min after drug intake; • Time to recovery in FEV1 (return to 85% of the baseline, i.e. post-diluent FEV1); • FEV1 AUC0-10min (normalised by time). • Change in Borg scale (used to estimate the breathlessnees intensity) , defined as the difference between the Borg scale obtained at the end of methacholine challenge test (before drug intake) and the Borg scale at 1, 3, 5, 10, 20 and 30 min after drug intake; • Time to recovery in Borg scale (50% decrease from the post-methacholine value). • Adverse Events and Adverse Drug Reactions • Vital signs (systolic, diastolic blood pressure and pulse rate) before the start of the methacholine challenge at all visits.;Timepoint(s) of evaluation of this end point: within 30 minutes after study drug inhalation as reliever therapy | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed