Status unknownNCT01014325Updated Nov 3, 2015

Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

A Phase 3 interventional study of Allergen extract and Placebo in Allergic Rhinitis, sponsored by Roxall Medizin. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Roxall Medizin · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Conditions studied

Allergic Rhinitis

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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's planned enrollment of 130 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Roxall Medizin is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Positive history of perennial allergic rhinitis
Positive screening skin prick test (wheal diameter > 3 mm)
Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
Signed and dated patient´s Informed Consent,

Exclusion criteria

Exclusion Criteria:

Previous immunotherapy with allergen extracts within the last 3 years,
Simultaneous participation in other clinical trials,
Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
Auto-immune disorders,
Severe chronic inflammatory diseases,
Malignancy,
Alcohol abuse,
Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 130 participants (estimated)

Study arms

Experimental
Allergen extract
Biological: Allergen extract
Placebo comparator
Placebo
Biological: Placebo

Interventions

BiologicalAllergen extract
sublingual application
BiologicalPlacebo
sublingual application

What researchers measure

Primary outcomes

Symptom and medication score
Time frame: 1 year

Secondary outcomes

Safety of sublingual application
Time frame: 1 year
Protocol of adverse events
Time frame: 1 year
Quality of Life Questionnaire
Time frame: 1 year
Evaluation of patients' related clinical global improvement
Time frame: 1 year

Study locations

1 site

Madrid, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01014325
Lead sponsor: Roxall Medizin
Responsible party: Sponsor
First posted: Nov 16, 2009
Start date: Sep 2016
Primary completion: Sep 2017 (estimated)
Completion: Sep 2017 (estimated)
Last update: Nov 3, 2015

Study contacts

Roxall Medizin

Contact

+49408972520

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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