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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783237
First received: October 30, 2008
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: December 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783237     History of Changes
Other Study ID Numbers: P03431
Study First Received: October 30, 2008
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on October 19, 2014