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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606242
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : March 10, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Information provided by:
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects
Study Start Date : January 2000
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low dose steroid
Fluticasone, 100 mcg per day
 Drug: Fluticasone
Inhaled Fluticasone, either 100 or 1000 mcg per day
Other Name: Flovent
Active Comparator: High dose steroid
Fluticasone, 1000 mcg per day
 Drug: Fluticasone
Inhaled Fluticasone, either 100 or 1000 mcg per day
Other Name: Flovent


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 [ Time Frame: Measured every 2 weeks ]

Secondary Outcome Measures :
  1. PC20 methacholine [ Time Frame: Measured every 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of asthma

Exclusion Criteria:

  • Habitual cigarette smoking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606242


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
More Information
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Responsible Party: John Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00606242    
Other Study ID Numbers: HL6788-15958-08
5P50HL056385 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents