Seasonal Allergic RhinitisPhase 4NCT00223587
Seasonal Allergic Rhinitis and Driving Ability
A Phase 4 study testing 1 week of treatment discontinuation in people with Seasonal Allergic Rhinitis, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- 1 week of treatment discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2004to Jan 2008
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- outpatients with seasonal allergic rhinitis
- a valid driver's licence
- written informed consent
- a T5SS score >8 during the allergic season and <3 in winter
Who cannot join
- use of medication or medical conditions that are known to affect driving ability
- associated ENT disease or asthma
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Utrecht Institute for Pharmaceutical Sciences
Utrecht, 3508TB
About this study
Official title: Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning
On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).
Read the detailed description
This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- 1 week of treatment discontinuation
- Keywords
- driving, memory
- 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.
1 week of treatment discontinuationOther
1 week of treatment discontinuation during allergic rhinitis season
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1 week of treatment discontinuation Receives: Other: 1 week of treatment discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
Measured: allergic season and winter
Secondary outcomes (2)
Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation]
Measured: allergic season and winter
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]
Measured: allergic season and winter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionJan 2008
Why it stopped: slow recruitment rate
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Edmund Volkerts, PhD, Study director, Utrecht Institute for Pharmaceutical SciencesJoris Verster, PhD, Principal investigator, Utrecht Institute for Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223587
- Sponsor's protocol ID
- 04/089-E
- Status last verified
- Apr 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning
- ClinicalTrials.gov ID
- NCT00223587
- Acronym / sponsor ID
- 04/089-E
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- driving, memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment rate
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Sep 2005 (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.
On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).
Detailed description
This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: 1 week of treatment discontinuation1 week of treatment discontinuation |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- outpatients with seasonal allergic rhinitis
- a valid driver's licence
- written informed consent
- a T5SS score >8 during the allergic season and <3 in winter
Key exclusion criteria (2 listed)
- use of medication or medical conditions that are known to affect driving ability
- associated ENT disease or asthma
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 |
|---|---|---|
| 1 week of treatment discontinuation1 week of treatment discontinuation during allergic rhinitis season | Other | A |
Primary outcome
Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
Time frame: allergic season and winter
2 secondary outcomes
Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation]
Time frame: allergic season and winter
Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]
Time frame: allergic season and winter
Results and safety
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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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.
Edmund Volkerts, PhD study director
Utrecht Institute for Pharmaceutical Sciences
Joris Verster, PhD principal investigator
Utrecht Institute for Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1 week of treatment discontinuation in people with Seasonal Allergic Rhinitis, run by Utrecht Institute for Pharmaceutical Sciences 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Apr 2008. 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. 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?
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
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?
Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation] (time frame: allergic season and winter). 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 15 Apr 2008.