Relative Potency of Inhaled Corticosteroids | NCT00292838

Studies
Relative Potency of Inhaled Corticosteroids

NCT00292838

Sponsor

St. Joseph's Healthcare Hamilton

Status

Completed

Last Update Posted

Jul 20, 2011Estimated

Enrollment

Phase

Phase 4

Conditions

Asthma
Chronic Obstructive Pulmonary Disease (COPD)

Interventions

fluticasone 25, 50, 100, 200 mcg

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 2011

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 2001

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 16, 2006Estimated

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

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.

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

Name	Type	Description	Arm Group Labels	Other Names
fluticasone 25, 50, 100, 200 mcg	Drug

Measure	Description	Time Frame
Sputum eosinophils

Measure	Description	Time Frame
Exhaled nitric oxide, FEV1, FEF25-75%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sputum eosinophilia >3%
Adults age 18-70 years
History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
FEV1 ≥ 60% predicted
Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
Able to give written informed consent

Exclusion Criteria:

Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
Relevant seasonal allergen exposure within 4 weeks or within the course of the study
Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
Other respiratory diseases
Women who are pregnant or unwilling to use appropriate contraception during the study
Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederick E Hargreave, MD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Firestone Institute for Respiratory Health, St. Joseph's Healthcare		Hamilton	Ontario	L8N 4A6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided