The primary objective of this study is to evaluate the effects of two types of AR treatment & placebo in counteracting AR*s effects on Cognition and Driving. Therefore, the effects of nasal provocation in AR patients on cognitive functions and…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following outcome variable will be used to evaluate the primary objectives:
Study parameter : Standard Highway Test
Outcome variable: Standard Deviation of Lateral Position (SDLP): cm.
Outcome variable: Standard Deviation of Speed (SDSP): km.
.
Study parameter : WLT- 15 verbal Memory test
Outcome variable: Total words recalled (Immediate recall)
Outcome variable: Total words recalled after 30 minutes (delayed recall)
Secondary outcome
An exploratory Health Cost analysis will be performed on treated vs untreated
AR.
Variable: Cost effectiveness analysis
Outcome variable: PRODISQ procedure as described by Koopmanschap et al 2005
Background summary
Previous research has shown that patients suffering from Allergic Rhinitis (AR)
not only suffer from direct symptoms of their condition but also report a
decreased quality of life. More specific this relates not only to psychological
wellbeing but also to diminished cognitive functions such as memory and
concentration (Kremer et al., 2001). In a recent study of our group we showed
that in tasks with a higher and longer lasting cognitive load symptomatic AR
patients performed significantly worse compared to controls (Hartgerink-Lutgens
et al., 2009).
The finding of a direct relationship between AR symptoms and cognitive
functioning strongly suggests implications of AR daily life functioning, safety
and workplace productivity. Whereas untreated AR was previously thought only to
affect subjective wellbeing it now seems that cognitive functioning might be
directly impaired which could lead to potentially dangerous situations in daily
life such as driving a car or operating machinery. This would add an argument
to re-evaluate treatment protocols that are now mainly aimed at reducing AR
symptoms and increased wellbeing.
In this study we will investigate the effect of an allergen challenge in AR
patients on actual driving and memory functions. A comparison in performance
will be made between untreated patients and patients treated with systemic or
topical drugs.
Hartgerink-Lutgens I., Vermeeren A., Vuurman E., Kremer B. Disturbed cognitive
functions after nasal provocation in patients with Seasonal Allergic Rhinitis.
Clinical and Experimental Allergy. Published online: 18 February 2009.
Kremer, B., et al., Generic or disease-specific quality of life scales to
characterize health status in
allergic rhinitis? Allergy, 2001. 56(10): p. 957-63.
Study objective
The primary objective of this study is to evaluate the effects of two types of
AR treatment & placebo in counteracting AR*s effects on Cognition and Driving.
Therefore, the effects of nasal provocation in AR patients on cognitive
functions and actual driving performance after treatment will be determined.
Study design
This will be a single-centre, randomized, double-blind, placebo-controlled
4-way crossover study conducted in twenty AR patients between 21-40 years of
age. Participants who qualify will enter the study and be tested on 4 different
occasions outside the pollen season. Participants will be randomized to one of
four computer generated sequences and the actual provocation phase will be
conducted using a cross over design. There will be four test conditions, and
all participantss will participate in all four conditions. Treatments are a
systemic treatment (cetirizine 10mg), a topical treatment (fluticasonfuroaat)
and placebo. Nasal challenge consists of either vivodiagnost® allergen or
placebo.
There will be at least a 14 day washout between treatments. This will lead to 4
conditions for patients:
1. Placebo Nasal challenge + placebo treatment
2. Nasal challenge + placebo treatment
3. Nasal challenge + systemic treatment
4. Nasal challenge + topical treatment
Each treatment phase will consist of one day of testing + treatment plus a
5-day period immediately preceding each test day in which only topical
treatment will be administered. The schedules and procedures will be identical
for all four periods(conditions) of the study. All patients will be collected
from their homes by a study assistant and transported to the Institute. After
testing is concluded at the end of the test day they will also be returned to
their homes.
On each test day subjects will first fill out a few questionnaires. Then a
nasal provocation will be administered to elicit an allergic reaction and
subjects will receive a dose of active drug or placebo. After two hours
subjects will perform a standard Highway driving test lasting 60 minutes during
which a memory test is administered. After conclusion of the driving test the
subject fill out a second set of questionnaires and are dismissed.
Intervention
All subjects will go through the following for conditions with treatments:
Condition 1. Placebo Nasal challenge + placebo treatment
Condition 2. Nasal challenge + placebo treatment
Condition 3. Nasal challenge + systemic treatment (Cetirizine 10mg)
Condition 4. Nasal challenge + topical treatment (Fluticasonfuroaat 27,5
microgram)
Study burden and risks
The burden on participants is limited. Time investment is limited to 4 full
mornings and a test session of about 3 hours. No exceptional mental or physical
strain is imposed on participants. The procedures of the driving test have been
proven to be safe in over 70 projects completed with the procedure previously.
The provocation procedure is administered routinely in diagnosis of SAR.
Finally, the drugs used have been on the market for over two years and have no
known or expected serious side effects.
postbus 616
6200MD Maastricht
NL
postbus 616
6200MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
1 Participants must be normal healthy males or females, age between 21 and 45 years, diagnosed with seasonal AR (SAR), also known as Intermittent Rhinitis (ITR) Anti-allergic treatment during the previous season, positive radioallergosorbent test for serum-specific immunoglobulin E or positive skin prick test for tree/ and/or grass- and/or weed pollen.
2. Participants must be experienced drivers. That is, each shall have held a driver*s license for at least the preceding two years and shall have driven more than 5,000 km/yr (3,000 miles/yr) during that period.
3.Participants must be in general good health as confirmed by routine clinical and laboratory testing.
4 Participants must be able and willing to give Informed consent
Exclusion criteria
1. Participants who have clinically significant abnormal physical findings or vital signs at the Screening physical examination (as determined by the Investigator) which could interfere with the objectives of the study. This includes participants who have any history or symptoms of chronic illness including asthma, history of psychotic disorders, drug addiction or abuse of drugs or alcohol which could interfere with the completion of the study.
2.Participants requiring any CNS medication during the study, or medication with sedative effects which could interfere with the objectives of the study.
3.Participants who have taken participated in an investigational drug trial within one month prior to the Screening Visit.
4. Participants with a history of allergies to more than two classes of medication or who are allergic to or cannot tolerate antihistamines.
5. Excessive smoking; i.e., more than ten cigarettes per day or the equivalent.
6. Excessive consumption of beverages containing caffeine; i.e., more than five cups per day.
7. Participants with active seasonal and/ or perennial allergic rhinitis.
8. Pregnant or nursing females.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021933-30-NL |
| ClinicalTrials.gov | nct01239264 |
| CCMO | NL33269.068.10 |