Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00783237

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 IV

Drug Information available for: Mometasone furoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis

Further study details as provided by Schering-Plough:

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
Mometasone Furoate Nasal Spray: Experimental	Drug: Mometasone Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
Placebo Nasal Spray: Placebo Comparator	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

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03431
Study First Received:	October 30, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00783237
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Mometasone furoate
Rhinitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009