In short
Ketotifen is an antiallergic substance being studied as a nasal spray for rhinitis. One Phase 2 trial is currently authorised in the EU, planning to enrol 120 patients. The trial compares two strengths of ketotifen nasal spray with a marketed cromoglycate nasal spray and placebo. Ketotifen has also been studied in children with asthma as an oral medicine.
Key points
- Ketotifen is being studied as a nasal spray in rhinitis in a Phase 2 trial.
- The trial plans to enrol 120 patients and is currently authorised in the EU.
- Two strengths are being tested: 0.025% and 0.050% ketotifen nasal spray.
- The main measure is the change in rhinitis symptom score (VAS) from baseline to week 12.
- The comparison arms are placebo nasal spray and cromoglycate nasal spray 2%.
- Ketotifen has also been studied as an oral medicine for asthma in children.
What is ketotifen?
Ketotifen is an antiallergic substance that has been studied as a medicine for allergic conditions. In the EU Clinical Trials Information System (CTIS), it is being investigated as a nasal spray for rhinitis in a Phase 2 trial. Ketotifen has also been described as an orally active, prophylactic anti-asthmatic drug in a published study. The trial record lists the product as ketotifen nasal spray in two strengths, 0.025% and 0.050%.
How does ketotifen work?
Ketotifen is an antiallergic substance. The trial record describes it as a nasal spray intended to reduce rhinitis symptoms, but does not explain the molecular mechanism. The supplementary source describes ketotifen as a prophylactic anti-asthmatic drug, meaning it is used to prevent symptoms rather than treat an acute attack. No further detail on the mechanism of action is available in the provided sources.
Which conditions is ketotifen used or studied for?
- Rhinitis — inflammation of the nose causing symptoms such as sneezing, runny or blocked nose. The Phase 2 trial studies ketotifen nasal spray in patients with rhinitis.
- Asthma in children — a published trial compared ketotifen with placebo in 20 children over three months.
How is ketotifen given?
In the current EU trial, ketotifen is given as a nasal spray in two strengths: 0.025% (0.25 mg/mL) and 0.050% (0.50 mg/mL). The trial record lists the route as nasal use. The supplementary source describes ketotifen as an orally active drug in the context of asthma prophylaxis in children.
What do the clinical trials show?
One Phase 2 trial is registered in the EU CTIS for ketotifen nasal spray in rhinitis. The trial is currently authorised and plans to enrol 120 patients. It is an interventional study comparing two strengths of ketotifen nasal spray (0.025% and 0.050%) with a marketed cromoglycate nasal spray 2% and placebo. The primary outcome is the change in the patient symptom sumscore measured on a visual analogue scale (VAS) from baseline to week 12. The trial explores whether the new low-dose and high-dose formulations of ketotifen nasal spray improve rhinitis symptoms after 4 weeks and 12 weeks of treatment compared to baseline.
A separate published study in children with asthma compared oral ketotifen with placebo over three months. Children receiving ketotifen were more likely to reduce concomitant medications and showed significant improvement in asthma scores and certain measures of lung function.
What side effects are known?
The published study in children with asthma reported that children receiving ketotifen had a significantly increased incidence of dry mouth and significant weight gain compared with those receiving placebo. No side effect information for the nasal spray formulation is available in the provided sources.