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Completed

NCT Number: NCT00783237

Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone

Drug

Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)

Other names: Nasonex, SCH 032088

Placebo

Drug

Placebo nasal spray, single dose of 2 sprays per nostril

Primary outcomes

  1. Total Nasal Symptom Score (TNSS)

    Time frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours

Secondary outcomes

  1. Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response

    Time frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 31, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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