Allergic Rhinitis Clinical Trial
Official title:
Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.
Status | Completed |
Enrollment | 340 |
Est. completion date | February 21, 2004 |
Est. primary completion date | February 21, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - at least 12 years old, - had a history of SAR to ragweed pollen for at least one year - had a positive skin test (prick) to short ragweed allergen. - if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit - were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control. Exclusion Criteria: - developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions; - had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment; - had an upper respiratory or sinus infection within two weeks prior to treatment; - had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis; - were female subjects who were pregnant, breast feeding, or premenarchal; - could not adhere to concomitant medication prohibitions; - had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray; - had asthma that requires systemic or inhaled corticosteroid treatment; - had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow; - had rhinitis medicamentosa; - had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Berger WE, Nayak AS, Staudinger HW. Mometasone furoate improves congestion in patients with moderate-to-severe seasonal allergic rhinitis. Ann Pharmacother. 2005 Dec;39(12):1984-9. Epub 2005 Nov 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Nasal Symptom Score (TNSS) | On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours | ||
Secondary | Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response | On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours |
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