Seasonal Allergic RhinitisNCT01318681
Rhinitis, Cognition and Driving Performance
A study testing cetirizine 10 mg and fluticasone furoate in people with Seasonal Allergic Rhinitis and Driving Ability, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis, Driving Ability, Cognition
- What is being tested?
- cetirizine 10 mg and fluticasone furoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers known with Seasonal Allergic Rhinitis
- Experienced drivers holding a license
- 21- 45 years of age
Who cannot join
- Asthma or other chronic illness
- current psychoactive medication
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance
This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)
- Conditions
- Seasonal Allergic Rhinitis, Driving Ability, Cognition
- Being tested
- cetirizine 10 mg, fluticasone furoate, placebo
- Keywords
- driving, memory, cognition
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetirizine 10 mgDrug
cetirizine 10 mg over encapsulated
fluticasone furoateDrug
nasal spray 25ug per dose
placeboDrug
a placebo nasal spray and placebo capsule are available for double dummy treatment
| Study group | Role | What they receive |
|---|---|---|
| Pollen provocation with systemic treatment | Experimental | Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution Receives: Drug: cetirizine 10 mg |
| Pollen provocation with topical treatment | Experimental | treatment with 25ug fluticasone furoate after a nasal pollen challenge Receives: Drug: fluticasone furoate |
| placebo treatment after pollen challenge | Placebo comparator | Placebo treatment after a nasal challenge with pollen solution Receives: Drug: placebo |
| control condition | No intervention | A placebo drug is administered after a sham nasal challenge with a pollen solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP) in highway driving
Standard Deviation of Lateral Position (SDLP) is the amount of "weaving" that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving
Measured: 2:00 - 3:00 hrs post dosing
Secondary outcomes (1)
Word Learning Test (WLT-15) verbal memory score
Subjects are presented with a list of 15 words at a rate of one word/second with a pause between words of one second. Immediately following the presentation subjects are asked to recall and name as many words as possible. The total number of words recalled after three repeated presentations of the same list of words is the outcome variable
Measured: 2:30 hrs post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vuurman, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318681
- Sponsor's protocol ID
- EPU-055
- Status last verified
- Mar 2011
- First submitted
- 17 Mar 2011
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance
- ClinicalTrials.gov ID
- NCT01318681
- Acronym / sponsor ID
- EPU-055
- Conditions
- Seasonal Allergic Rhinitis, Driving Ability, Cognition
- Keywords
- driving, memory, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pollen provocation with systemic treatment | Experimental | Drug: cetirizine 10 mgSubjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution |
| Pollen provocation with topical treatment | Experimental | Drug: fluticasone furoatetreatment with 25ug fluticasone furoate after a nasal pollen challenge |
| placebo treatment after pollen challenge | Placebo comparator | Drug: placeboPlacebo treatment after a nasal challenge with pollen solution |
| control condition | No intervention | –A placebo drug is administered after a sham nasal challenge with a pollen solution |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers known with Seasonal Allergic Rhinitis
- Experienced drivers holding a license
- 21- 45 years of age
Key exclusion criteria (3 listed)
- Asthma or other chronic illness
- current psychoactive medication
- History of drug abuse
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 |
|---|---|---|
| cetirizine 10 mgcetirizine 10 mg over encapsulated | Drug | Pollen provocation with systemic treatment |
| fluticasone furoatenasal spray 25ug per dose | Drug | Pollen provocation with topical treatment |
| placeboa placebo nasal spray and placebo capsule are available for double dummy treatment | Drug | placebo treatment after pollen challenge |
Primary outcome
Standard Deviation of Lateral Position (SDLP) in highway driving
Time frame: 2:00 - 3:00 hrs post dosing
Standard Deviation of Lateral Position (SDLP) is the amount of "weaving" that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving
1 secondary outcome
Word Learning Test (WLT-15) verbal memory score
Time frame: 2:30 hrs post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetirizine 10 mg and fluticasone furoate in people with Seasonal Allergic Rhinitis and Driving Ability, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 3 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standard Deviation of Lateral Position (SDLP) in highway driving (time frame: 2:00 - 3:00 hrs post dosing). 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 8 Nov 2013.