NCT00605410

Brief Summary

Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

January 7, 2009

Status Verified

July 1, 2008

Enrollment Period

3 months

First QC Date

January 18, 2008

Last Update Submit

January 6, 2009

Conditions

Asthma

Keywords

Methacholine bronchoprovocationAntimuscarinic

Outcome Measures

Primary Outcomes (1)

  • methacholine PC20

    6hours and 12 hours post inhalation

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: ipratropium bromide

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

ipratropium bromideDRUG

2 puffs (40 micrograms) 2 puffs (0micrograms)

Also known as: Atrovent HFA Inhalation Aerosol
1
placeboDRUG

Matched placebo

2

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of asthma; stable and controlled
  • FEV1 greater than or equal to 65% predicted

You may not qualify if:

  • Concomitant lung disease other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N oW8, Canada

Location

Related Publications (1)

  • Illamperuma C, Davis BE, Fenton ME, Cockcroft DW. Duration of bronchoprotection of inhaled ipratropium against inhaled methacholine. Ann Allergy Asthma Immunol. 2009 May;102(5):438-9. doi: 10.1016/S1081-1206(10)60519-4. No abstract available.

    PMID: 19496252DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Donald W Cockcroft, MD

    Department of Medicine University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 7, 2009

Record last verified: 2008-07

Locations

CA(1)