Seasonal Allergic RhinitisPhase 4NCT00997620
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
A Phase 4 study testing Fluticasone furoate Nasal Spray 110 mcg in people with Seasonal Allergic Rhinitis, run by Western Sky Medical Research.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Fluticasone furoate Nasal Spray 110 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
Read the detailed description
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Fluticasone furoate Nasal Spray 110 mcg, Placebo
- Keywords
- Hay Fever, Daytime somnolence, Cognition
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate Nasal Spray 110 mcgDrug
Also called Fluticasone Furoate Nasal Spray
Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.
PlaceboDrug
Also called Placebo Veramyst Nasal Spray
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis. Receives: Drug: Placebo |
| Fluticasone Furoate | Experimental | IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis Receives: Drug: Fluticasone furoate Nasal Spray 110 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance
The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.
Measured: over 2 weeks
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.
The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.
Measured: after 2 weeks intervention
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.
Measured: over 2 weeks
Secondary outcomes (3)
Change in Epworth Sleep Scale
The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.
Measured: Baseline and after 2 weeks intervention
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire
In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.
Measured: 2 weeks
Nasal Symptom Scores
Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sky Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Lyndon Mansfield, Western Sky Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997620
- Sponsor's protocol ID
- 2008-4
- Status last verified
- May 2018
- First submitted
- 15 Oct 2009
- Last updated
- 18 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: This a single study site and at end IPD will be used in analyis by PI
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00997620
- Acronym / sponsor ID
- 2008-4
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Hay Fever, Daytime somnolence, Cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Western Sky Medical ResearchUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis. |
| Fluticasone Furoate | Experimental | Drug: Fluticasone furoate Nasal Spray 110 mcgIFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone furoate Nasal Spray 110 mcgAlso: Fluticasone Furoate Nasal SprayFluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations. | Drug | Fluticasone Furoate |
| PlaceboAlso: Placebo Veramyst Nasal SprayFluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations. | Drug | Placebo |
Primary outcome
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance
Time frame: over 2 weeks
The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.
Time frame: after 2 weeks intervention
The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
Time frame: over 2 weeks
The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.
3 secondary outcomes
Change in Epworth Sleep Scale
Time frame: Baseline and after 2 weeks intervention
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire
Time frame: 2 weeks
Nasal Symptom Scores
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. This a single study site and at end IPD will be used in analyis by PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone furoate Nasal Spray 110 mcg in people with Seasonal Allergic Rhinitis, run by Western Sky Medical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance (time frame: over 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.