Allergic RhinitisPhase 4F1NCT02576041
Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
A Phase 4 study testing Bilastine in people with Allergic Rhinitis and Urticaria, run by Menarini International Operations Luxembourg SA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Allergic Rhinitis, Urticaria
- What is being tested?
- Bilastine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Dec 2015
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Allergic Rhinitis, Urticaria
- Being tested
- Bilastine, Placebo
- Keywords
- driving simulator
- Medical subject headings
- Rhinitis, Allergic, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Also called Robilas
Bilastine tablets once a day for 7+3 days
PlaceboDrug
Placebo tablets once a day during 7+3 days run in period
| Study group | Role | What they receive |
|---|---|---|
| Placebo (run-in); Bilastine | Experimental | 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). Receives: Drug: Bilastine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7+3 days of active treatment
Secondary outcomes (2)
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.
Measured: 7±3 days of active treatment
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.
Measured: 7±3 days of active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
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 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrizia Pepe, Principal investigator, Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576041
- Sponsor's protocol ID
- MEIN/14/Bil-ARU/001
- Other IDs
- 2015-001313-26, 2015
- Acronym
- F1
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2015
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
- ClinicalTrials.gov ID
- NCT02576041
- Acronym / sponsor ID
- F1 / MEIN/14/Bil-ARU/001
- Conditions
- Allergic Rhinitis, Urticaria
- Keywords
- driving simulator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Menarini International Operations Luxembourg SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 16 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo (run-in); Bilastine | Experimental | Drug: Bilastine, Drug: PlaceboAt 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). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (28 listed)
- 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;
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 |
|---|---|---|
| BilastineAlso: RobilasBilastine tablets once a day for 7+3 days | Drug | Placebo (run-in); Bilastine |
| PlaceboPlacebo tablets once a day during 7+3 days run in period | Drug | Placebo (run-in); Bilastine |
Primary outcome
Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test
Time frame: 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.
2 secondary outcomes
Maintenance of Constant Speed Evaluated During the F1 Simulator
Time frame: 7±3 days of active treatment
Time to Reaction Evaluated During the F1 Simulator
Time frame: 7±3 days of active treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Patrizia Pepe principal investigator
Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena
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 Bilastine in people with Allergic Rhinitis and Urticaria, run by Menarini International Operations Luxembourg SA at 1 site in Italy.
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 10 inclusion and 28 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 Apr 2017. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2017). 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?
Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test (time frame: 7+3 days of active treatment). 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 Apr 2017.