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Study Of RV-39 In Patients Who Also Have Asthma

NCT ID: NCT00503009

Last Updated: 2016-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Detailed Description

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Conditions

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Asthma

Keywords

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Rhinovirus Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

fluticasone propionate/salmeterol

Intervention Type DRUG

comparator

Arm 2

Group Type ACTIVE_COMPARATOR

fluticasone propionate

Intervention Type DRUG

Comparator

Arm 3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo

Interventions

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fluticasone propionate/salmeterol

comparator

Intervention Type DRUG

fluticasone propionate

Comparator

Intervention Type DRUG

placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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fluticasone propionate

Eligibility Criteria

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Inclusion Criteria

* Have asthma for at least 3 months prior to the study.
* Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
* Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
* Have a positive allergic status antibody test.

Exclusion Criteria

* Have a history of life-threatening asthma.
* Been hospitalized for asthma within the 24 months prior to the study.
* Have certain conditions that would make study participation unsafe.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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HZA109895

Identifier Type: -

Identifier Source: org_study_id