NCT03108534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

April 5, 2017

Last Update Submit

October 2, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change in FEV1 5-min post-dose

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

    5 min post-dose

Secondary Outcomes (5)

  • Change in FEV1 other time points

    Up to 30 min post-dose

  • FEV1 AUC0-10min

    From dosing to 10 min post-dose

  • Time to recovery in FEV1

    From dosing to 30 min post-dose

  • Change in Borg scale

    Up to 30 min post-dose

  • Time to recovery in Borg scale

    Up to 30 min post-dose

Study Arms (3)

CHF1535 NEXThaler

EXPERIMENTAL

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

Drug: CHF1535 NEXThaler

CHF1535 pMDI

ACTIVE COMPARATOR

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

Drug: CHF1535 pMDI

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CHF1535 NEXThalerDRUG

Rescue treatment

Also known as: Foster NEXThaler
CHF1535 NEXThaler
CHF1535 pMDIDRUG

Rescue treatment

Also known as: Foster
CHF1535 pMDI
PlaceboDRUG

Rescue treatment

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Dundee

Dundee, United Kingdom

Location

Hammersmith Medicines Research

London, United Kingdom

Location

Medicines Evaluation Unit

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

February 28, 2017

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations

GB(3)