Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00691665
First received: June 3, 2008
Last updated: March 23, 2010
Last verified: March 2010
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Purpose
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Olopatadine HCL Nasal Spray, 0.6% Drug: Fluticasone Propionate Nasal Spray, 50 mcg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Hay Fever
Drug Information available for:
Fluticasone propionate
Fluticasone
Olopatadine
Olopatadine hydrochloride
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline [ Time Frame: 14 Days minus baseline ] [ Designated as safety issue: No ]Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
- Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline [ Time Frame: 14 days minus baseline ] [ Designated as safety issue: No ]Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.
- Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline [ Time Frame: 14 Days minus baseline ] [ Designated as safety issue: No ]Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.
- Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline [ Time Frame: 14 Days minus baseline ] [ Designated as safety issue: No ]Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.
| Enrollment: | 130 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Olopatadine HCL Nasal Spray, 0.6%
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
|
Drug: Olopatadine HCL Nasal Spray, 0.6%
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
|
|
Active Comparator: Fluticasone Propionate Nasal Spray, 50 mcg
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
|
Drug: Fluticasone Propionate Nasal Spray, 50 mcg
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion:
- A history of spring/summer seasonal allergies.
- Positive skin prick test for the currently prevalent allergen of the area.
- Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
- For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.
Exclusion:
- History of chronic sinusitis.
- Asthma, with the exception of intermittent asthma.
- Smokers.
- Known non-responders to antihistamines.
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
- Chronic use of long acting antihistamines.
- Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
- Relatives of study site staff or other individuals who had access to the clinical study protocol.
- Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Michael Edwards, PhD, Alcon Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00691665 History of Changes |
| Other Study ID Numbers: | SMA-08-06 |
| Study First Received: | June 3, 2008 |
| Results First Received: | January 26, 2010 |
| Last Updated: | March 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Rhinitis Seasonal Allergic Rhinitis allergies |
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 Fluticasone Olopatadine Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal |
ClinicalTrials.gov processed this record on May 21, 2013