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NCT00845195
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Phase 4 trial testing Olopatadine HCl Nasal Spray, 0.6% in Seasonal Allergic Rhinitis in 150 participants. Completed.
1 May 2009
Quick facts
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 March 2009 |
| Primary completion | 1 May 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Olopatadine HCl Nasal Spray, 0.6% — full drug profile →
- Azelastine HCl Nasal Spray, 0.1% — full drug profile →
Conditions studied
- Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →
Sponsor
Alcon Research — full company profile →
Who can join
12 and older, any sex, with Seasonal Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
Time frame: 14 days minus baseline
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 m -
Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
Time frame: 14 days minus baseline
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 max -
Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline
Time frame: 14 days minus baseline
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), th -
Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Time frame: 14 days minus baseline
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
Sponsor's own description
The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00845195
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Seasonal Allergic Rhinitis
Currently open trials in the same condition.
- NCT07055542 — Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study · NA · recruiting
- NCT06846385 — Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic · Phase 2, PHASE3 · recruiting
- NCT07291284 — Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis · Phase 3 · active not recruiting
- NCT06300203 — Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis · Phase 2 · recruiting
- NCT04815668 — Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis · NA · recruiting
Other Alcon Research trials
Trials by the same sponsor.
- NCT06884202 — Evaluation of Delefilcon A Contact Lenses · NA · completed
- NCT06784063 — Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs) · NA · completed
- NCT06571656 — Evaluation of the Safety and Tolerability of Ocular Lubricants · NA · terminated
- NCT06660290 — A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes · Phase 3 · completed
- NCT06483113 — DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00845195 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alcon Research
- Last refreshed: 22 April 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00845195.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing