Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00435461
First received: February 14, 2007
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
| Condition | Intervention | Phase |
|---|---|---|
|
Hayfever Allergic Rhinitis |
Drug: Fluticasone furoate and fexofenadine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis |
Resource links provided by NLM:
MedlinePlus related topics:
Hay Fever
Drug Information available for:
Fluticasone propionate
Fexofenadine
Fluticasone
Fexofenadine hydrochloride
Fluticasone furoate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Mean change from baseline over the two-week treatment period in the nighttime symptoms score (NSS)
Secondary Outcome Measures:
- Mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Fluticasone furoate and fexofenadine
Other Name: Fluticasone furoate and fexofenadine
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Informed consent.
- Outpatient.
- Females of child-bearing potential must use appropriate contraception.
- Diagnosis of seasonal allergic rhinitis to mountain cedar.
- Adequate exposure to allergen.
- Able to comply with study procedures.
- Literate.
Exclusion criteria:
- Significant concomitant medical condition.
- Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
- Positive pregnancy test.
- Allergy to any component of the investigational product.
- Tobacco use
- Contact lens use
- Has chickenpox or measles or recent exposure
- Other clinical trial drug exposure in last 30 days
- Affiliation with clinic site
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435461
Locations
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78750 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78731 | |
| GSK Investigational Site | |
| Kerrville, Texas, United States, 78028 | |
| GSK Investigational Site | |
| New Braunfels, Texas, United States, 78130 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78205 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00435461 History of Changes |
| Other Study ID Numbers: | FFU109045 |
| Study First Received: | February 14, 2007 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
allergic rhinitis mountain cedar once daily fluticasone furoate fexofenadine |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Fluticasone Fexofenadine Terfenadine Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013