Duration of Protective Effect From Inhaled Ipratropium Br... | NCT00605410

Studies
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

NCT00605410

Sponsor

University of Saskatchewan

Status

Completed

Last Update Posted

Jan 7, 2009Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Asthma

Interventions

ipratropium bromide
placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 18, 2008

First Submission Date that Met QC Criteria

Jan 30, 2008

First Posted Date

Jan 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2009

Last Update Posted Date

Jan 7, 2009Estimated

Name	Class
Royal University Hospital Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: ipratropium bromide
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ipratropium bromide	Drug	2 puffs (40 micrograms) 2 puffs (0micrograms)	1

Measure	Description	Time Frame
methacholine PC20		6hours and 12 hours post inhalation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Concomitant lung disease other than asthma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald W Cockcroft, MD	Department of Medicine University of Saskatchewan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Saskatchewan		Saskatoon	Saskatchewan	S7N oW8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19496252	Derived	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds