Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00728416
First received: July 31, 2008
Last updated: March 11, 2010
Last verified: March 2010
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Purpose
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Mometasone furoate nasal spray (MFNS) Drug: Matching placebo nasal spray |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 Mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR) |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days [ Time Frame: 15 days of treatment ] [ Designated as safety issue: No ]Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])
Secondary Outcome Measures:
- Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days [ Time Frame: 15 days of treatment ] [ Designated as safety issue: No ]Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])
| Enrollment: | 333 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Drug: Mometasone furoate nasal spray (MFNS)
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Other Name: Nasonex Nasal Spray
|
|
Placebo Comparator: Arm 2
Matching placebo nasal spray
|
Drug: Matching placebo nasal spray
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A subject must be 12 years of age or older, of either sex, and of any race.
- A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- A subject must be clinically symptomatic at the Screening and Baseline Visits.
Exclusion Criteria:
- A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- A subject who is participating in any other clinical study.
- A subject who is part of the staff personnel directly involved with this study.
- A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
- A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- A subject previously randomized into this study.
- A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
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: | NCT00728416 History of Changes |
| Other Study ID Numbers: | P05583 |
| Study First Received: | July 31, 2008 |
| Results First Received: | October 9, 2009 |
| Last Updated: | March 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Respiratory Tract Infections Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013