Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria (F1)

• ClinicalTrials.gov Identifier: NCT02576041
• Recruitment Status: Completed
• First Posted: October 15, 2015
• Results First Posted: January 16, 2017
• Last Update Posted: April 18, 2017
• Sponsor: Menarini International Operations Luxembourg SA
• Information provided by (Responsible Party): Menarini International Operations Luxembourg SA

Tracking Information

• First Submitted Date: October 13, 2015
• First Posted Date: October 15, 2015
• Results First Submitted Date: September 22, 2016
• Results First Posted Date: January 16, 2017
• Last Update Posted Date: April 18, 2017
• Study Start Date: October 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2016)

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.

• Original Primary Outcome Measures (submitted: October 13, 2015): Standard Deviation Lateral Position (SDLP) evaluated during the F1 simulator test [ Time Frame: 7±3 days of active treatment ]

Current Secondary Outcome Measures (submitted: November 18, 2016)

• Maintenance of Constant Speed Evaluated During the F1 Simulator [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 13, 2015)

• Maintenance of constant speed evaluated during the F1 simulator [ Time Frame: 7±3 days of active treatment ]
• Delay in changing gear 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
• Official Title: Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Allergic Rhinitis
• Urticaria

Intervention

• Drug: Bilastine
  Bilastine tablets once a day for 7+3 days
  Other Name: Robilas
• Drug: Placebo
  Placebo tablets once a day during 7+3 days run in period

Study Arms

Experimental: 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).

Interventions:

• Drug: Bilastine
• Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2016): 19
• Original Estimated Enrollment (submitted: October 13, 2015): 18
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02576041
• Other Study ID Numbers: MEIN/14/Bil-ARU/001; 2015-001313-26 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Menarini International Operations Luxembourg SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Menarini International Operations Luxembourg SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Patrizia Pepe; Allergology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena

• PRS Account: Menarini International Operations Luxembourg SA
• Verification Date: March 2017