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NCT00540631: ACRI
A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale
Phase 3 trial testing specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) in Rhinoconjunctivitis in 108 participants. Completed in 1 December 2011.
1 August 2010
Quick facts
| Lead sponsor | Allergopharma GmbH & Co. KG |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 October 2007 |
| Primary completion | 1 August 2010 |
| Estimated completion | 1 December 2011 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) — full drug profile →
Conditions studied
- Rhinoconjunctivitis — all drugs for Rhinoconjunctivitis →
Sponsor
Allergopharma GmbH & Co. KG — full company profile →
Who can join
Adults 18 to 60, any sex, with 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.
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The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline
Time frame: November 2007 - February 2010
Sponsor's own description
Multicenter Immunotherapy House Dust Mite Allergoid
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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The evidence for commercial house dust mite immunotherapy products: A pragmatic systematic review with narrative synthesis.
West T, Katelaris CH. · · 2024 · cited 3× · PMID 39092213 · DOI 10.1016/j.jacig.2024.100255
Verify or expand the search:
- PubMed search for NCT00540631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Allergopharma GmbH & Co. KG trials
Trials by the same sponsor.
- NCT07096440 — Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites · not yet 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 NCT00540631 (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 Allergopharma GmbH & Co. KG
- Last refreshed: 8 February 2013
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/NCT00540631.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing