NCT00606242

Brief Summary

This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jan 2000

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2014

Enrollment Period

2.9 years

First QC Date

January 21, 2008

Last Update Submit

March 6, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • FEV1

    Measured every 2 weeks

Secondary Outcomes (1)

  • PC20 methacholine

    Measured every 2 weeks

Study Arms (2)

Low dose steroid

ACTIVE COMPARATOR

Fluticasone, 100 mcg per day

Drug: Fluticasone

High dose steroid

ACTIVE COMPARATOR

Fluticasone, 1000 mcg per day

Drug: Fluticasone

Interventions

FluticasoneDRUG

Inhaled Fluticasone, either 100 or 1000 mcg per day

Also known as: Flovent
High dose steroidLow dose steroid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of asthma

You may not qualify if:

  • Habitual cigarette smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2002

Study Completion

December 1, 2007

Last Updated

March 10, 2014

Record last verified: 2014-03

Locations

US(1)