Investigators from multiple institutions in Finland conducted a randomized trial to assess the effectiveness of intermittent tiotropium bromide, a selective long-acting anticholinergic drug, for treatment of episodic wheezing in young children. Study participants were children 6-35 months old with 2-4 previous physician-confirmed episodes of wheeze and/or shortness of breath. At enrollment, participants were randomized to 1 of 3 treatment groups: tiotropium bromide plus as-needed albuterol (tiotropium group), fluticasone propionate plus as-needed albuterol (fluticasone group), or albuterol only (albuterol only group). All medications were administered via metered-dose inhalers with spacers. Parents of study children were instructed to begin use of the assigned regimen at the onset of a respiratory tract infection and use albuterol as needed during a 48-week study period. Tiotropium, 5 μg, was administered once daily, and fluticasone, 125 μg, was administered twice daily for 7-14 days during each episode of respiratory infection; albuterol sulfate 0.2 mg, was provided as needed 4-6 times daily in all groups. Parents recorded respiratory symptoms in their child on a daily basis and documented use of rescue albuterol in a diary throughout the study period. The primary outcome was number of symptom-free days, defined as days with no wheeze or shortness of breath. Secondary outcomes included number of doses of albuterol administered and early discontinuation of the study due to troublesome respiratory symptoms. Pairwise differences between treatment groups were assessed with Mann-Whitney U, chi-square, or Fisher exact tests.
Data were analyzed on 80 children, including 27 in the tiotropium group, 25 in the fluticasone group, and 28 randomized to albuterol only. The mean ages at enrollment were 21.4 ±7.0, 20.0 ±6.8, and 22.1 ±6.0 months, respectively, for participants in the 3 treatment groups. The median number of episodes of respiratory symptoms treated with study medications was 5 for children in the tiotropium group, 6 for those in the fluticasone group, and 5 for participants randomized to albuterol only. During the 48-week study period, the percentage of symptom-free days was significantly greater among children receiving tiotropium than in those receiving fluticasone (median, 97% vs 87%; P = 0.002) and in those randomized to albuterol only (97% vs 88%; P = 0.003). The median number of doses of albuterol administered to participants in the tiotropium group (11) was significantly less than those receiving fluticasone (122) or albuterol only (80); P <0.001 and P = 0.005, respectively. Three participants in the tiotropium group dropped out of the study because of troublesome respiratory symptoms, compared to 6 in the fluticasone group (P = 0.098) and 13 in the albuterol only group (P = 0.004).
The authors conclude that intermittent tiotropium may be an effective treatment for episodic wheezing in young children.
Dr Chan has disclosed no financial relationship relevant to this commentary. This commentary does not contain...