Related Experiment Video
Updated: Aug 2, 2026
Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019
A multicentre randomized placebo-controlled double-blind study on the efficacy of Ketotifen in infants with chronic
P P van Asperen1, K O McKay, C M Mellis
1Department of Respiratory Medicine, Children's Hospital, Camperdown, New South Wales, Australia.
Insights
Ketotifen did not show a significant benefit over placebo for treating cough and wheeze in infants. Placebo treatment resulted in more symptom-free days, though the difference was not clinically significant.
Area of Science:
- Pediatrics
- Pharmacology
Background:
- Infants aged 6-36 months often experience chronic cough and/or wheeze.
- Assessing the efficacy of pharmacological interventions in this age group is crucial.
Purpose of the Study:
- To evaluate the therapeutic efficacy of Ketotifen compared to placebo in infants with chronic cough and/or wheeze.
Main Methods:
- A multicenter, randomized, placebo-controlled, double-blind study.
- 113 infants (6-36 months) underwent a 4-week baseline, 16-week treatment (Ketotifen or placebo syrup), and 4-week wash-out phase.
- Parental diary cards tracked cough, wheeze, and medication use daily.
Main Results:
- The percentage of symptom-free days decreased significantly in both Ketotifen and placebo groups (P < 0.005).
- Placebo-treated infants had significantly more symptom-free days than Ketotifen-treated infants (P < 0.01), but the difference was <10% per period.
- Symptom severity and beta-agonist use were lower in the placebo group, but not statistically significant.
Conclusions:
- Ketotifen did not demonstrate a therapeutic advantage over placebo for chronic cough and/or wheeze in infants.
- The observed statistical advantage for placebo was not considered clinically relevant.
Abstract:
The efficacy of Ketotifen was examined in the treatment of 113 infants between 6 and 36 months of age presenting with a history of cough and/or wheeze in a multicentre randomized placebo-controlled double-blind study. A 4 week no-medication baseline phase preceded the 16 week treatment phase in which infants took 2.5 mL twice daily of either placebo or Ketotifen (0.5 mg) syrup; this was followed by a 4 week wash-out phase. Diary card evaluation was performed by the parent or guardian for the duration of the study and recorded wheeze and cough twice daily as well as medication used. The percentage of symptom-free days decreased significantly in both groups (P < 0.005) with placebo-treated infants experiencing significantly more symptom-free days compared with the Ketotifen group (P < 0.01), although this difference was never more than 10% in any 4 week treatment period. Symptom severity scores and use of beta-agonist medication were also less in the placebo-treated infants but did not reach statistical significance. This study was unable to show a therapeutic advantage of Ketotifen over placebo in this group of infants with chronic cough and/or wheeze and the apparent statistical advantage of placebo is not a clinically relevant finding.
Related Concept Videos
01:23Upper Respiratory Drugs: Antitussives, Expectorants, and Mucolytics
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla. Benzonatate operates peripherally within the respiratory tract by anesthetizing...
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms: