Effects of a single dose of Bilastine 20mg on flying ability in healthy volunteers under conditions of simulated cabin pressure
report
Background : Optimal physical and mental fitness of pilots is a prerequisite for flight safety. Pilots suffering from allergic rhinoconjuctivitis or other allergic upper airway diseases are not allowed to fly because ambient pressure changes may aggravate the symptoms and some antihistaminic medication may interfere with flight safety, probably due to their sedative effects. Bilastine is a new second-generation highly selective H1 antihistamine that has been developed for the treatment of allergic rhinoconjunctivitis and urticaria. Bilastine is considered to have no sedative side effects and no cardiotoxic effects and may, therefore, provide a safe therapeutic alternative to keep pilots suffering from allergic rhinitis on flying status.
Objective : To determine the response over time on daytime alertness and performance following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa, which equals the minimum pressure in an airliner cabin.
Methods : In a double-blind crossover study, 24 subjects randomly received a single oral dose of bilastine 20 mg, hydroxyzine 50 mg, or placebo. On test days, pre-dose (baseline) levels of alertness and performance were determined, as were post-dose levels at selected time points, with the use of objective (vigilance, complex tasks) and subjective tests, tailored to the specific tasks of aircrew. All tests were applied under hypobaric conditions that prevail in an intact cockpit.
Results : Bilastine had no detrimental effects on sleepiness and performance of tasks associated with flying ability in healthy subjects under simulated cabin pressure conditions for up to 6 hours post-dose. Conversely, hydroxyzine (active control) was associated with significant sleepiness and impaired performance on flying ability tasks across this time period, confirming the sensitivity of the tests used.
Conclusion : A single oral dose of bilastine 20 mg did not cause sleepiness and did not impair the performance of tasks associated with flying ability. It is anticipated that a single oral dose of bilastine 20 mg will not affect flying performance.
This finding might also have implications for the treatment of allergic disorders of personnel involved in other highly skilled jobs.
Objective : To determine the response over time on daytime alertness and performance following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa, which equals the minimum pressure in an airliner cabin.
Methods : In a double-blind crossover study, 24 subjects randomly received a single oral dose of bilastine 20 mg, hydroxyzine 50 mg, or placebo. On test days, pre-dose (baseline) levels of alertness and performance were determined, as were post-dose levels at selected time points, with the use of objective (vigilance, complex tasks) and subjective tests, tailored to the specific tasks of aircrew. All tests were applied under hypobaric conditions that prevail in an intact cockpit.
Results : Bilastine had no detrimental effects on sleepiness and performance of tasks associated with flying ability in healthy subjects under simulated cabin pressure conditions for up to 6 hours post-dose. Conversely, hydroxyzine (active control) was associated with significant sleepiness and impaired performance on flying ability tasks across this time period, confirming the sensitivity of the tests used.
Conclusion : A single oral dose of bilastine 20 mg did not cause sleepiness and did not impair the performance of tasks associated with flying ability. It is anticipated that a single oral dose of bilastine 20 mg will not affect flying performance.
This finding might also have implications for the treatment of allergic disorders of personnel involved in other highly skilled jobs.
Topics
TNO Identifier
528554
Publisher
TNO
Collation
60 p. (incl. appendices)
Place of publication
Soesterberg