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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Actual Primary Completion Date : February 21, 2004
Actual 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 site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. 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