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NCT01591343
Prospective Study to Evaluate the Safety of a 4-month Treatment With Depigoid® Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml) in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Mild Persistent or Intermittent Asthma
Phase 2 trial testing Depigoid® (500 DPP/ml) in Allergic Rhinitis in 8 participants. Terminated before completion.
1 July 2012
Quick facts
| Lead sponsor | Laboratorios Leti, S.L. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 8 |
| Start date | 1 June 2012 |
| Primary completion | 1 July 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 10 locations across Spain |
Drugs / interventions tested
- Depigoid® (500 DPP/ml) — full drug profile →
Conditions studied
- Allergic Rhinitis — all drugs for Allergic Rhinitis →
- Rhinoconjunctivitis — all drugs for Rhinoconjunctivitis →
- Mild Persistent Asthma — all drugs for Mild Persistent Asthma →
- Mild Intermittent Asthma — all drugs for Mild Intermittent Asthma →
Sponsor
Laboratorios Leti, S.L. — full company profile →
Who can join
Adults 18 to 55, any sex, with Allergic Rhinitis or Rhinoconjunctivitis. 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.
-
Primary variable
Time frame: 4 months
Number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Sponsor's own description
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma. Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01591343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01591343 (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: 21 February 2018
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/NCT01591343.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing