NCT03315000

Brief Summary

The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Oct 2017

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 13, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 16, 2017

Last Update Submit

October 9, 2018

Conditions

Asthma

Keywords

methacholineairway hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

  • Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment

    assessed by dose shift of geometric mean methacholine PC20 data

    baseline versus 30 min post-treatment

Secondary Outcomes (1)

  • Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment

    baseline versus 24 hours post-treatment

Study Arms (3)

Vilanterol

EXPERIMENTAL

Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler

Drug: Vilanterol and Fluticasone Furoate

Fluticasone

EXPERIMENTAL

Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler

Drug: Fluticasone Furoate

Placebo

PLACEBO COMPARATOR

Lactose powder inhaled through Ellipta® inhaler

Drug: Placebos

Interventions

Vilanterol and Fluticasone FuroateDRUG

Same as vilanterol arm description

Also known as: Breo
Vilanterol
Fluticasone FuroateDRUG

Same as fluticasone arm description

Also known as: Arnuity
Fluticasone
PlacebosDRUG

Same as placebo arm description

Also known as: lactose powder
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
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
  • FEV1 greater than or equal to 65% of predicted

You may not qualify if:

  • Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study
  • pregnant or nursing
  • diabetes
  • hypokalemia
  • cardiovascular, prostate, kidney, or urinary retention problems
  • lactose-intolerant
  • allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study
  • current smokers
  • past smokers with smoking history \>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)

  • Westbury GLM, Blais CM, Davis BE, Cockcroft DW. Bronchoprotective effect of vilanterol against methacholine-induced bronchoconstriction in mild asthmatics: A randomized three-way crossover study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):328-332. doi: 10.1016/j.anai.2018.07.005. Epub 2018 Jul 12.

    PMID: 30017826DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

vilanterolfluticasone furoateFluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic 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
Professor, Department of Medicine

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

October 13, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Journal Publication

Locations

CA(1)