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Completed

NCT Number: NCT02622243

Duration of Long Acting Muscarinic Antagonist (LAMA) Bronchoprotection Against Methacholine Challenge

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

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma Research Lab

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tiotropium

Drug

long acting muscarinic antagonist

Other names: Spiriva

Glycopyrronium

Drug

long acting muscarinic antagonist

Other names: Seebri

Respimat

Device

inhaler device used to deliver active tiotropium or placebo

BREEZEHALER

Device

inhaler device used to deliver active glycopyrronium or placebo

Primary outcomes

  1. Change from baseline methacholine bronchoprotection at 96 hours

    Time frame: pre treatment versus 96 hour post treatment

    assessed by dose shift of geometric mean methacholine PC20 data

Secondary outcomes

  1. Change from baseline methacholine bronchoprotection at 1 hour

    Time frame: pre treatment versus 1 hour post treatment

    assessed by dose shift of geometric mean methacholine PC20 data

  2. Change from baseline methacholine bronchoprotection at 24 hours

    Time frame: pre treatment versus 24 hours post treatment

    assessed by dose shift of geometric mean methacholine PC20 data

  3. Change from baseline methacholine bronchoprotection at 48 hours

    Time frame: pre treatment versus 48 hours post treatment

    assessed by dose shift of geometric mean methacholine PC20 data

  4. Change from baseline methacholine bronchoprotection at 72 hours

    Time frame: pre treatment versus 72 hours post treatment

    assessed by dose shift of geometric mean methacholine PC20 data

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Duration of Bronchoprotection of the Long Acting Muscarinic Antagonists Tiotropium and Glycopyrronium Against Methacholine Induced Bronchoconstriction

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Apr 20, 2016

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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