Randomized, observer-blind, placebo-controlled, four Parallel Group, Clinical Trial for exploring the Efficacy and Tolerability of two different strengths ketotifen nasal spray (Ketotifen 0.025 mcg/ml and 0.050 mcg/ml) vs sodium cromoglicate nasal spray 2% in Patients with Rhinitis

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525419-16-00

Enrollment

120

Registered

2026-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis

Brief summary

Change in VAS score in the patient symptom sumscore [from final visit (week 12) to baseline]

Detailed description

Change in VAS score in the patient symptom sumscore [from follow-up visit (week 4) to baseline], Change in iTNSS from final visit (week 12) to baseline, Change in iTNSS from follow-up visit (week 4) to baseline, Change in ARS score from final visit (week 12) to baseline, Change in ARS score from follow-up visit (week 4) to baseline

Interventions

DRUGPlacebo Nasal Spray

DRUGKetotifen 0.050% (0.50 mg/mL)

DRUGCromo-ratiopharm® Nasenspray

DRUGKetotifen 0.025% (0.25mg/mL)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in VAS score in the patient symptom sumscore [from final visit (week 12) to baseline]	—

Secondary

Measure	Time frame
Change in VAS score in the patient symptom sumscore [from follow-up visit (week 4) to baseline], Change in iTNSS from final visit (week 12) to baseline, Change in iTNSS from follow-up visit (week 4) to baseline, Change in ARS score from final visit (week 12) to baseline, Change in ARS score from follow-up visit (week 4) to baseline	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 17, 2026