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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF1535 NEXThaler

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

Group Type EXPERIMENTAL

CHF1535 NEXThaler

Intervention Type DRUG

Rescue treatment

CHF1535 pMDI

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

Group Type ACTIVE_COMPARATOR

CHF1535 pMDI

Intervention Type DRUG

Rescue treatment

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Rescue treatment

Interventions

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CHF1535 NEXThaler

Rescue treatment

Intervention Type DRUG

CHF1535 pMDI

Rescue treatment

Intervention Type DRUG

Placebo

Rescue treatment

Intervention Type DRUG

Other Intervention Names

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Foster NEXThaler Foster

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No