Study Of Patients With Allergic Rhinitis And Asthma - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00296530

Purpose

This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. 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.

Condition	Intervention	Phase
Asthma Allergic Rhinitis	Drug: fluticasone propionate/salmeterol Drug: fluticasone propionate Drug: montelukast	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Montelukast sodium Montelukast Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Morning Peak Expiratory Flow

Secondary Outcome Measures:

Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days

Estimated Enrollment:	600
Study Start Date:	September 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
Have a positive allergy skin test.

Exclusion Criteria:

Have a history of life-threatening asthma.
Been hospitalized for asthma within the 6 months prior to the study.
Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296530

Show 74 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ADA103578
Study First Received:	February 23, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00296530
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Asthma
Allergic Rhinitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Salmeterol
Asthma
Rhinitis
Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009