NCT02953041

Brief Summary

The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

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

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

October 24, 2016

Last Update Submit

June 12, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline methacholine bronchoprotection at 1 hour

    assessed by dose shift of geometric mean methacholine PC20 data

    baseline versus 1 hour post-treatment

Secondary Outcomes (2)

  • Change from baseline methacholine bronchoprotection at 24 hours

    baseline versus 24 hours post-treatment

  • Change from baseline methacholine bronchoprotection at 48 hours

    baseline versus 48 hours post-treatment

Study Arms (3)

LAMA Treatment

EXPERIMENTAL

Inhalation of 50mcg glycopyrronium from Breezhaler device 1 hour prior to methacholine challenge

Drug: Glycopyrronium

uLABA Treatment

EXPERIMENTAL

Inhalation of 75mcg indacaterol from Breezhaler device 1 hour prior to methacholine challenge

Drug: Indacaterol

Combo Treatment

EXPERIMENTAL

Inhalation of 50mcg glycopyrronium from one Breezhaler device, and 75mcg indacaterol from a second Breezhaler device, all one hour prior to methacholine challenge

Drug: GlycopyrroniumDrug: Indacaterol

Interventions

GlycopyrroniumDRUG

long-acting muscarinic antagonist

Also known as: Seebri, Glycopyrrolate, Glycopyrronium bromide
Combo TreatmentLAMA Treatment
IndacaterolDRUG

ultra long-acting beta agonist

Also known as: Onbrez
Combo TreatmentuLABA Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women aged 18 or older
  • stable mild-to-moderate asthma
  • baseline methacholine PC20 less than or equal to 8mg/mL and FEV1 greater than or equal to 65% of predicted (asthmatic participants)
  • baseline methacholine PC20 greater than 16mg/mL (healthy participants)

You may not qualify if:

  • use of long-acting bronchodilators or long-acting muscarinic antagonists within 30 days of Visit 1
  • pregnant or lactating
  • cardiovascular, prostate, kidney or urinary retention problems
  • respiratory illness within 4 weeks of Visit 1
  • allergen-induced asthma exacerbating within 4 weeks of Visit 1
  • hypokalemia
  • diabetes
  • glaucoma
  • smokers and exsmokers with greater than 10 pack years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma Research Lab, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • Blais CM, Davis BE, Cockcroft DW. The effect of glycopyrronium and indacaterol, as monotherapy and in combination, on the methacholine dose-response curve of mild asthmatics: a randomized three-way crossover study. Respir Res. 2017 Aug 2;18(1):146. doi: 10.1186/s12931-017-0628-4.

    PMID: 28768531DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Glycopyrrolateindacaterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Don Cockcroft, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 2, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 9, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Journal Publication

Locations

CA(1)