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

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: CHF1535 pMDI; Drug: CHF1535 NEXThaler; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03108534

2016-003672-47 (EudraCT Number)

CCD-01535BD1-01

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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65 participants in 3 patient groups, including a placebo group

CHF1535 NEXThaler

Experimental group

Description:

CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)

Treatment:

Drug: CHF1535 NEXThaler

CHF1535 pMDI

Active Comparator group

Description:

CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)

Treatment:

Drug: CHF1535 pMDI

Placebo

Placebo Comparator group

Description:

Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler

Treatment:

Drug: Placebo