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

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ClinicalTrials.gov Identifier: NCT00783237
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Mometasone Drug: Placebo Phase 4

Merck Sharp & Dohme Corp. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
Actual Study Start Date : December 1, 2003
Primary Completion Date : February 21, 2004
Study Completion Date : February 21, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mometasone Furoate Nasal Spray Drug: Mometasone
Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
Other Name: Nasonex, SCH 032088
Placebo Comparator: Placebo Nasal Spray Drug: Placebo
Placebo nasal spray, single dose of 2 sprays per nostril

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783237     History of Changes
Other Study ID Numbers: P03431
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents