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NCT00916422
Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass Pollen
Phase 3 trial testing Allergen extract (Phleum pratense) in Seasonal Allergic Rhinitis in 153 participants. Completed in 1 October 2013.
1 January 2013
Quick facts
| Lead sponsor | Laboratorios Leti, S.L. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 153 |
| Start date | 1 June 2008 |
| Primary completion | 1 January 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 23 locations across Hungary, Spain |
Drugs / interventions tested
- Allergen extract (Phleum pratense) — full drug profile →
- Placebo
Conditions studied
- Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →
Sponsor
Laboratorios Leti, S.L. — full company profile →
Who can join
Adults 18 to 55, 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.
-
Symptoms and medication score recorded by subjects
Time frame: 2 year
Sponsor's own description
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense pollen in the treatment of patients affected by allergic rhinitis/ rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the Score regarding Symptoms and consumption of the medication.
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 NCT00916422
- 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
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 NCT00916422 (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 Laboratorios Leti, S.L.
- Last refreshed: 28 January 2014
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/NCT00916422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing