Fluticasone Furoate Versus Placebo in Treating Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Western Sky Medical Research
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Lyndon Mansfield, Western Sky Medical Research
ClinicalTrials.gov Identifier:
NCT00997620
First received: October 15, 2009
Last updated: June 27, 2012
Last verified: June 2012
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Purpose
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Fluticasone furoate Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness |
Resource links provided by NLM:
Further study details as provided by Western Sky Medical Research:
Primary Outcome Measures:
- Performance on Test of Variables of Attention (TOVA) - a standardized test of cognitive performance [ Time Frame: over 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Epworth sleep scale [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- Nocturnal Rhinoconjunctivitis Quality of Life Questionaire [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- Nasal Symptom Scores [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 41 |
| Study Start Date: | March 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo for comparison
|
Drug: Placebo
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
|
|
Active Comparator: Fluticasone Furoate
Active treatment
|
Drug: Fluticasone furoate
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Other Name: Veramyst
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.
- Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.
- A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.
- Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.
- Ability to read, understand and give informed consent.
- Ability to understand and carry out responsibilities of the study
Exclusion Criteria:
- Any chronic disease or other acute disease, which could influence central nervous system.
- The use of any medication, which could affect central nervous system function.
- Unwillingness to participate in the study.
- Inability to understand testing procedures or use of medication.
- Hypersensitivity to fluticasone or vehicle of nasal sprays.
- Any sleep disorders including obstructive sleep apnea.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Lyndon Mansfield, Director, Western Sky Medical Research |
| ClinicalTrials.gov Identifier: | NCT00997620 History of Changes |
| Other Study ID Numbers: | 2008-4 |
| Study First Received: | October 15, 2009 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Western Sky Medical Research:
|
Hay Fever Daytime somnolence Cognition |
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 |
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 |
ClinicalTrials.gov processed this record on May 22, 2013