title: The effect of nebulized salbutamol or isotonic saline on exercise-induced bronchoconstriction in elite skaters following a 1,500-meter race: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Prevalence of exercise-induced bronchoconstriction (EIB) is high in elite athletes, especially after many years training in cold and dry air conditions. The primary treatment of EIB is inhaling a short-acting beta-2-agonist such as salbutamol. However, professional speed skaters also inhale nebulized isotonic saline or tap water before and after a race or intense training. The use of nebulized isotonic saline or tap water to prevent EIB has not been studied before, raising questions about safety and efficacy. The aim of this study is to analyze the acute effect of nebulized isotonic saline or salbutamol on EIB in elite speed skaters following a 1,500-meter race.
  
  
  METHODS
  This randomized controlled trial compares single dose treatment of 1 mg nebulized salbutamol in 4 mL of isotonic saline, or with 5 mL of isotonic saline. A minimum of 13 participants will be allocated in each treatment group. Participants should be between 18 and 35 years of age and able to skate 1,500 m in less than 2 min 10 s (women) or 2 min 05 s (men). Repeated measurements of spirometry, forced oscillation technique, and electromyography will be performed before and after an official 1,500-m race. Primary outcome of the study is the difference in fall in FEV1 after exercise in the different treatment groups. The trial is currently enrolling participants.
  
  
  CONCLUSIONS
  Elite athletes run the risk of pulmonary inflammation and remodeling as a consequence of their frequent exercise, and thus increased ventilation in cold and dry environments. Although inhalation of nebulized isotonic saline is commonplace, no study has ever investigated the safety or efficacy of this treatment.
  
  
  BACKGROUND
  This trial protocol was registered with the Dutch trial registration for clinical trials under number NTR3550.
authors.affiliation: Sports Medicine, Tjongerschans Hospital, Heerenveen, the Netherlands. jean.driessen@tjongerschans.nl
authors.forename: Jean M M
authors.initials: JM
authors.lastname: Driessen
authors.forename: Margryt
authors.initials: M
authors.lastname: Gerritsma
authors.forename: Jaap
authors.initials: J
authors.lastname: Westbroek
authors.forename: Nick H T
authors.initials: NH
authors.lastname: ten Hacken
authors.forename: Frans H C
authors.initials: FH
authors.lastname: de Jongh
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000336:Aerosols; D000420:Albuterol / Q000008:administration & dosage*; D001250:Asthma, Exercise-Induced / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D016084:Bronchoconstriction / Q000187:drug effects*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D004311:Double-Blind Method; D004576:Electromyography; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007552:Isotonic Solutions; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D009330:Nebulizers and Vaporizers; D009426:Netherlands; D009991:Oscillometry; D011446:Prospective Studies; D012107:Research Design; D012861:Skating; D012965:Sodium Chloride / Q000008:administration & dosage* / Q000009:adverse effects; D013147:Spirometry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000336:Aerosols; D001993:Bronchodilator Agents; D007552:Isotonic Solutions; D012965:Sodium Chloride; D000420:Albuterol