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NCT00263640
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis
Phase 3 trial testing Acaroid in Respiratory Hypersensitivity in 130 participants. Completed in 1 August 2012.
1 April 2009
Quick facts
| Lead sponsor | Allergopharma GmbH & Co. KG |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 1 May 2005 |
| Primary completion | 1 April 2009 |
| Estimated completion | 1 August 2012 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Acaroid — full drug profile →
- Placebo
Conditions studied
- Respiratory Hypersensitivity — all drugs for Respiratory Hypersensitivity →
Sponsor
Allergopharma GmbH & Co. KG — full company profile →
Who can join
Adults 6 to 40, any sex, with Respiratory Hypersensitivity. 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.
-
Inhalative dose of fluticasone propionate
Time frame: After 2 years
The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.
Sponsor's own description
The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanisms of Particles in Sensitization, Effector Function and Therapy of Allergic Disease.
Joubert IA, Geppert M, Johnson L, Mills-Goodlet R, et al · · 2020 · cited 17× · PMID 32714326 · DOI 10.3389/fimmu.2020.01334 -
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 NCT00263640
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Respiratory Hypersensitivity
Currently open trials in the same condition.
- NCT06624696 — Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane An · Phase 4 · recruiting
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 NCT00263640 (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: 14 January 2015
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/NCT00263640.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing