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Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00606242
Acronym
FluSAL
Enrollment
44
Registered
2008-02-01
Start date
2000-01-31
Completion date
2007-12-31
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGFluticasone

Inhaled Fluticasone, either 100 or 1000 mcg per day

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
GlaxoSmithKline
CollaboratorINDUSTRY
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of asthma

Exclusion criteria

* Habitual cigarette smoking

Design outcomes

Primary

MeasureTime frame
FEV1Measured every 2 weeks

Secondary

MeasureTime frame
PC20 methacholineMeasured every 2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026