A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

• Status: Completed
• Trial end date: 2017-09-19
• Target enrollment: 0
• Participant gender: All

Summary

The clinical trial is designed to evaluate 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 (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Methacholine Chloride

Criteria

Inclusion Criteria:

• Informed consent form obtained

• Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler

• Pre-bronchodilator FEV1 of at least 65%

• Positive response to methacholine challenge test

• Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines

• For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.

Exclusion Criteria:

• Clinically relevant and uncontrolled concomitant diseases

• Abnormal clinically relevant ECG

• Presence of aortic aneurism

• Uncontrolled hypertension

• Intake of non-permitted concomitant medications

• Participation in another clinical trials in the previous 8 weeks

• Seasonal variation in asthma

• Recent occurrence of asthma exacerbations

• Hypersensitivity to any product used in the trial, including excipients

• Heavy caffeine drinkers

• History of alcohol/drug abuse

• Smokers