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Completed

NCT Number: NCT03108534

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

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Dundee, Dundee, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHF1535 NEXThaler

Drug

Rescue treatment

Other names: Foster NEXThaler

CHF1535 pMDI

Drug

Rescue treatment

Other names: Foster

Placebo

Drug

Rescue treatment

Primary outcomes

  1. Change in FEV1 5-min post-dose

    Time frame: 5 min post-dose

    Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)

Secondary outcomes

  1. Change in FEV1 other time points

    Time frame: Up to 30 min post-dose

    Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)

  2. FEV1 AUC0-10min

    Time frame: From dosing to 10 min post-dose

    FEV1 area under the curve from dosing to 10 min post-dose

  3. Time to recovery in FEV1

    Time frame: From dosing to 30 min post-dose

    Time to return to 85% of baseline value

  4. Change in Borg scale

    Time frame: Up to 30 min post-dose

    Change in Borg scale from the end of the methacholine challenge test

  5. Time to recovery in Borg scale

    Time frame: Up to 30 min post-dose

    50% decrease from the post-methacholine challenge value

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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