Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00783237
First received: October 30, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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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 |
Schering-Plough 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 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 |
|---|---|
| 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00783237 History of Changes |
| Other Study ID Numbers: | P03431 |
| Study First Received: | October 30, 2008 |
| Last Updated: | October 30, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013