Allergic Rhinitis, Urticaria
Conditions
Keywords
driving simulator
Brief summary
The aim of the study is to evaluate the effects of Bilastine on patients' attention and reactivity levels by measuring psychophysical performance at a F1-high speed simulator driving test.
Detailed description
This was a phase IV, interventional, prospective, mono-centric, single arm, uncontrolled, open label trial. The study included outpatient affected by Allergic Rhinitis and/or Chronic Urticaria, responding to inclusive criteria and able to perform a preliminary driving test on F1-high speed simulator (at the simulator centre) without experiencing signs or symptoms of intolerance towards the drive simulation (e.g., nausea, vomiting or dizziness etc). Each subject underwent 3 ambulatory visits at the hospital site and 3 driving test at the simulator centre.
Interventions
DRUGBilastine
Bilastine tablets once a day for 7+3 days
DRUGPlacebo
Placebo tablets once a day during 7+3 days run in period
Sponsors
Menarini International Operations Luxembourg SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients affected by allergic rhinitis (seasonal or perennial) or urticaria (induced and not induced) who need histamine H1-receptor antagonist therapy according to PI therapeutic decision; * Males and females aged between 21 and 55 years; * Body Mass Index (BMI) between 19 and 30 kg/m2 (included); * If women: negative pregnant test and contraception from at least 30 days before the study (Visit V-1) and up to the end of the study. For women patients the negative pregnant test will be acquired before the Simulator performance (Visit V-1H); * Subjects having a valid driving license from more than 3 years; * Subjects having a driving experience of at least 5000 km per year; * Subjects able to understand the protocol and to come to the visits; * Subjects able to give a written informed consent; * Subjects who, at investigator's judgment, are likely to be compliant during the study and do not use potentially adulterating drugs; * Potential compliant subjects will be enrolled only if they tolerate driving the F1-simulator (starting from V-1 S).
Exclusion criteria
* Subjects with autoimmune urticaria; * Hypersensitivity to the active substance bilastine or to any of the excipients; * History or symptoms of severe mental or physical disorders or taking substance and alcohol; * Excessive smoking (more than 20 cigarettes per day), or consumption of caffeinated beverages (more than 6 cups per day); * Subjects who need unimpaired psychophysical condition due to their job; * Subjects with any non corrected visual defect or locomotor disorder which could interfere with the study; * Subjects ineligible at Visit V-1; * Subjects with known allergic reactions to antihistamines; * Subjects with porphyria; * Subjects with important sleep disturbances or kinetosis; * Subjects with clinically important (based on Investigator's judgment) renal or hepatic impairment, or gastrointestinal diseases (e.g. malabsorption); * Subjects with a medical history of seizure (i.e. epileptic related) or with current seizure; * Presence of significant medical condition/concomitant illnesses that, in the opinion of the Investigator, renders the patient immunocompromised or not suitable for a clinical trial or could adversely affect the subject's participation or evaluation in this study; * Subjects for whom, in the opinion of the Investigator, there is concern about compliance with the study procedures; * Presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract); * Presence of active cancer which requires chemotherapy or radiation therapy; * Presence of alcohol abuse or drug addiction; * Pregnancy or breast-feeding; * Treatment with: diuretics, corticosteroids (other than medication applied topically), central nervous system medications or medications with sedative effects (sleep inducing or antidepressant, sedative medications), medications that can interact with bilastine, other medications. In particular, patients treated with any of the following drugs will be excluded: * Imipramine antidepressants, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics; * Sedative antidepressants, monoamine oxidase (MAOI) inhibitors, barbiturates, benzodiazepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics, antitussives, replacement treatments), neuroleptics, anxiolytics; * Treatments with P-glycoprotein inhibitors (e.g. ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem), which may increase the plasmatic levels of bilastine; * Treatments that are substrates or inhibitors of OATP1A2 (e.g. ritonavir, rifampicin), which may decrease plasma concentrations of bilastine * Other treatments that can interact with bilastine (e.g. ketoconazole, erythromycin, diltiazem); Treatment with anticoagulants (e.g. warfarin); * Sedatives, hypnotics, tranquillizers or any other addictive agents; * Other treatments not admitted during the study: betahistine, anticholinesterases, arrhythmogenic drugs; * H2-antihistamines; * H1 antihistamines other than study medication or rescue medication. In any case, the possibility of inclusion of patients taking any of these drugs will be left at the Investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test | 7+3 days of active treatment | SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Constant Speed Evaluated During the F1 Simulator | 7±3 days of active treatment | Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered. |
| Time to Reaction Evaluated During the F1 Simulator | 7±3 days of active treatment | During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered. |
Countries
Italy
Participant flow
Pre-assignment details
Screening was performed in 2 separate sections, at hospital site (H) and at the simulator (S) center. A total of 19 patients were screened and only one discontinued study before starting placebo treatment due to agitation, sickness, transpiration and vomiting at the simulator driving test.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (run-in); Bilastine At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).
Bilastine: Bilastine tablets once a day for 7+3 days
Placebo: Placebo tablets once a day during 7+3 days run in period | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Placebo (run-in); Bilastine |
|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment Italy | 18 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test
SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.
Time frame: 7+3 days of active treatment
Population: The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilastine | Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test | -0.041 meters | Standard Deviation 0.047 |
Secondary
Maintenance of Constant Speed Evaluated During the F1 Simulator
Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.
Time frame: 7±3 days of active treatment
Population: The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilastine | Maintenance of Constant Speed Evaluated During the F1 Simulator | -1.397 Km/h | Standard Deviation 2.991 |
Secondary
Time to Reaction Evaluated During the F1 Simulator
During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.
Time frame: 7±3 days of active treatment
Population: Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilastine | Time to Reaction Evaluated During the F1 Simulator | Time reaction to Button A | -34.5 msec | Standard Deviation 95.71 |
| Bilastine | Time to Reaction Evaluated During the F1 Simulator | Time reaction to button B | -18.25 msec | Standard Deviation 66.28 |