NCT05381207|UnknownEarly Phase 1
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Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To examine the efficacy of Montelukast as an adjunct to INCS in patients with allergic rhinitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2022
Actual (reported)May 19, 2022
Actual (reported)October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Nasal symptoms
Participants will be asked to score five Sino-nasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4. This score will be assessed at the screening and follow-up visits at 12 weeks. The total five-symptom score (T5SS) was obtained with the sum of the individual symptoms (0-20).
3 monthes
laboratory findings
Evaluation of inflammatory markers levels (TNF-α, IL-6, IL-12) in inpatient blood At 0 point premedication (pre-medication) At 1 point post medication after 12 weeks (3 months)
3 months
Quality of life symptoms
Subjects will complete a validated questionnaire related to the general quality of life in patients with allergic rhinitis; this questionnaire records patients' symptoms The patients receive a rhino-conjunctivitis quality of life questionnaire. This questionnaire records domains like patient activities, sleep, ......and emotional problems on an 0-x ordinal scale.
3 monthes
Montelukast, 10 mg, oraly Local corticosteriod nasal spary
No drug taking , only local corticosteriod nasal spray
Subjects in group A (study) will be treated with Fluticasone Furoate nasal: (50 micrograms/spray) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 months. Subjects group B (control) will receive only topical steroids in an identical regimen
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
May 8, 2022
First Posted
May 19, 2022
Study Start
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2024
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 19, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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