ArticleClinical drug investigation2003
Efficacy and safety of ketotifen eye drops as adjunctive therapy to mometasone nasal spray in subjects with seasonal allergic rhinoconjunctivitis.
Article in Clinical drug investigation, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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0 citing papers in PubMed, 6 citations in OpenAlex.
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the efficacy and safety of ketotifen 0.025% ophthalmic solution (one drop/eye) with placebo as adjunctive therapy to mometasone nasal spray (50 microg/spray, two puffs/nostril) in subjects with seasonal allergic rhinoconjunctivitis (SARC). STUDY
designSingle-centre, randomised, double-masked, two-treatment, two-period crossover study.
setting8-hour allergen challenge in the Vienna Challenge Chamber. STUDY
participantsSubjects were >/=18 years old, had a >/=2-year history of SARC, and were sufficiently responsive to allergen challenge.
interventionsDuring each challenge, subjects received a single dose of mometasone + ketotifen or mometasone + placebo. MAIN OUTCOME MEASURES AND
results47 subjects were randomised, and 44 completed both treatment sequences. Efficacy was based on mean area under the curve (AUC) values for symptom relief scores over time, with the primary variable being the AUC 4-6 hours postdose (AUC(4-6)) for relief of ocular itching. Between-treatment differences were assessed using analysis of variance. While improvement in ocular itching (AUC(4-6)) was observed with both treatments, improvement was significantly (p = 0.014) better with mometasone + ketotifen versus mometasone + placebo, as was improvement based on AUC(0-6) (p = 0.009) and AUC(0-2) (p = 0.006). Similar trends (in favour of mometasone + ketotifen) were observed for improvements in ocular redness, running nose, sneezing and ocular/nasal composite scores (p </= 0.05). None of the safety findings (slit-lamp biomicroscopy, vital signs, adverse events) were clinically significant. One subject discontinued treatment due to mild pharyngitis.
conclusionKetotifen eye drops adjunctive to mometasone nasal spray provided greater relief of both ocular and nasal signs and symptoms than mometasone alone in subjects with SARC.
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Registered trials
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