A clinical trial to investigate the comparability of relief from methacholine-induced bronchoconstriction with CHF1535 100/6 µg NEXThaler® versus CHF1535 100/6 µg pMDI in asthmatic patients.
- Conditions
- AsthmaMedDRA version: 19.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-003672-47-GB
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- 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 < 5 pack years;
- Diagnosis of asthma for a minimum of 6 months;
- Pre-bronchodilator FEV1 = 65% of the predicted normal value and at
least 1.5 L;
- A positive response to methacholine challenge test and return to = 85% of baseline value after salbutamol intake;
- Previous treatment with low-medium doses of ICS or ICS plus
LABA (as per current GINA guidelines) for at least two months at stable doses;
- Applicable to WOCBP only: willing to use highly effective birth control method (if applicable), non-lactating and non-pregnant.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of CHF1535 100/6 µg NEXThaler®<br>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<br>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 Outcome Measures
Name Time Method Secondary end point(s): •Change in FEV1 (L) from post-diluent at 1, 10, 20 and 30 min after drug intake;<br>• Time to recovery in FEV1 (return to 85% of the baseline, i.e. post-diluent FEV1);<br>• FEV1 AUC0-10min (normalised by time).<br>• 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;<br>• Time to recovery in Borg scale (50% decrease from the post-methacholine value).<br>• Adverse Events and Adverse Drug Reactions <br>• 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