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NCT00712920
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
Phase 3 trial testing 0.15% azelastine hydrochloride in Perennial Allergic Rhinitis in 581 participants. Completed.
1 May 2008
Quick facts
| Lead sponsor | Meda Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 581 |
| Start date | 1 January 2007 |
| Primary completion | 1 May 2008 |
| Sites | 43 locations across United States |
Drugs / interventions tested
- 0.15% azelastine hydrochloride — full drug profile →
- 0.1% azelastine hydrochloride — full drug profile →
- Placebo
Conditions studied
- Perennial Allergic Rhinitis — all drugs for Perennial Allergic Rhinitis →
Sponsor
Meda Pharmaceuticals — full company profile →
Who can join
12 and older, any sex, with Perennial 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.
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Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
Time frame: baseline and 28 days
Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, tr
Sponsor's own description
The purpose of this study is to determine if two allergy medications are more effective than placebo.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis.
Bousquet J, Klimek L, Kuhl HC, Nguyen DT, et al · · 2023 · cited 4× · PMID 37920410 · DOI 10.3389/falgy.2023.1244012
Verify or expand the search:
- PubMed search for NCT00712920
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT00712920 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Meda Pharmaceuticals
- Last refreshed: 6 June 2011
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/NCT00712920.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing