NCT02622243

Brief Summary

The study will assess the duration of protection of single doses of 2 different long acting muscarinic antagonists against methacholine induced bronchoconstriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

November 27, 2015

Last Update Submit

April 19, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline methacholine bronchoprotection at 96 hours

    assessed by dose shift of geometric mean methacholine PC20 data

    pre treatment versus 96 hour post treatment

Secondary Outcomes (4)

  • Change from baseline methacholine bronchoprotection at 1 hour

    pre treatment versus 1 hour post treatment

  • Change from baseline methacholine bronchoprotection at 24 hours

    pre treatment versus 24 hours post treatment

  • Change from baseline methacholine bronchoprotection at 48 hours

    pre treatment versus 48 hours post treatment

  • Change from baseline methacholine bronchoprotection at 72 hours

    pre treatment versus 72 hours post treatment

Study Arms (2)

tiotropium

EXPERIMENTAL

2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge

Drug: TiotropiumDevice: RespimatDevice: Breezehaler

glycopyrronium

EXPERIMENTAL

1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge

Drug: glycopyrroniumDevice: RespimatDevice: Breezehaler

Interventions

TiotropiumDRUG

long acting muscarinic antagonist

Also known as: Spiriva
tiotropium
glycopyrroniumDRUG

long acting muscarinic antagonist

Also known as: Seebri
glycopyrronium
RespimatDEVICE

inhaler device used to deliver active tiotropium or placebo

glycopyrroniumtiotropium
BreezehalerDEVICE

inhaler device used to deliver active glycopyrronium or placebo

glycopyrroniumtiotropium

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female asthmatics \> 19 years of age
  • baseline methacholine PC20 less than or equal to 4mg/ml
  • baseline lung function \>65% predicted
  • non-smoker and less than 10 pack year smoking history

You may not qualify if:

  • use of anticholinergic within 30 days of Visit 1
  • poorly controlled asthma
  • pregnant or nursing
  • respiratory illness within 4 weeks of Visit 1
  • exposure to an agent that triggered asthma worsening (e.g. allergen) within 4 weeks of Visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma Research Lab

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • Blais CM, Davis BE, Cockcroft DW. Duration of bronchoprotection of the long-acting muscarinic antagonists tiotropium & glycopyrronium against methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2016 Sep;118:96-101. doi: 10.1016/j.rmed.2016.07.017. Epub 2016 Jul 30.

    PMID: 27578477DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium BromideGlycopyrrolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingQuaternary Ammonium CompoundsAminesOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-Ring

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
Professor

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 4, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

journal publication

Locations

CA(1)