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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
CHF1535 NEXThaler
CHF1535 pMDI
Placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Dundee
  • Hammersmith Medicines Research
  • Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CHF1535 NEXThaler

CHF1535 pMDI

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in FEV1 5-min post-dose
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)

Secondary Outcome Measures

Change in FEV1 other time points
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
FEV1 AUC0-10min
FEV1 area under the curve from dosing to 10 min post-dose
Time to recovery in FEV1
Time to return to 85% of baseline value
Change in Borg scale
Change in Borg scale from the end of the methacholine challenge test
Time to recovery in Borg scale
50% decrease from the post-methacholine challenge value

Full Information

First Posted
April 5, 2017
Last Updated
October 2, 2018
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03108534
Brief Title
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
September 19, 2017 (Actual)
Study Completion Date
September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF1535 NEXThaler
Arm Type
Experimental
Arm Description
CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
Arm Title
CHF1535 pMDI
Arm Type
Active Comparator
Arm Description
CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler
Intervention Type
Drug
Intervention Name(s)
CHF1535 NEXThaler
Other Intervention Name(s)
Foster NEXThaler
Intervention Description
Rescue treatment
Intervention Type
Drug
Intervention Name(s)
CHF1535 pMDI
Other Intervention Name(s)
Foster
Intervention Description
Rescue treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Rescue treatment
Primary Outcome Measure Information:
Title
Change in FEV1 5-min post-dose
Description
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Time Frame
5 min post-dose
Secondary Outcome Measure Information:
Title
Change in FEV1 other time points
Description
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Time Frame
Up to 30 min post-dose
Title
FEV1 AUC0-10min
Description
FEV1 area under the curve from dosing to 10 min post-dose
Time Frame
From dosing to 10 min post-dose
Title
Time to recovery in FEV1
Description
Time to return to 85% of baseline value
Time Frame
From dosing to 30 min post-dose
Title
Change in Borg scale
Description
Change in Borg scale from the end of the methacholine challenge test
Time Frame
Up to 30 min post-dose
Title
Time to recovery in Borg scale
Description
50% decrease from the post-methacholine challenge value
Time Frame
Up to 30 min post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Dundee
City
Dundee
Country
United Kingdom
Facility Name
Hammersmith Medicines Research
City
London
Country
United Kingdom
Facility Name
Medicines Evaluation Unit
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003672-47/results
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

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