CompletedNCT01012531Updated Jul 14, 2011

Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

A Phase 3 interventional study of Subcutaneous injections with highly polymerized allergen extract and Subcutaneous injection with placebo in Allergic Rhinitis, sponsored by Roxall Medizin. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-14.

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

Phase: Phase 3
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.

Conditions studied

Allergic Rhinitis

Browse trials for

In context

Rhinitis

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

This study's enrollment of 121 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 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
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 grass and/or rye pollen 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,
Patients being in any relationship or dependency with the sponsor and/or investigator,
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: 121 participants (actual)

Study arms

Active comparator
highly polymerized allergen extract
Biological: Subcutaneous injections with highly polymerized allergen extract
Placebo comparator
Placebo
Biological: Subcutaneous injection with placebo

Interventions

BiologicalSubcutaneous injections with highly polymerized allergen extract
cluster schedule
BiologicalSubcutaneous injection with placebo
cluster schedule

What researchers measure

Primary outcomes

Symptom and medication score
Time frame: 1 year

Secondary outcomes

Safety of the treatment during the study period
Time frame: 1 year
Documentation of adverse events
Time frame: 1 year
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
Time frame: 1 year
Global evaluation and Quality of life questionnaire
Time frame: 1 year

Study locations

1 site

Zentrum für Rhinologie und Allergologie
Wiesbaden, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01012531
Lead sponsor: Roxall Medizin
First posted: Nov 13, 2009
Start date: Oct 2008
Primary completion: Nov 2009
Completion: Dec 2009
Last update: Jul 14, 2011

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis→

Other studies from this sponsor

Roxall Medizin

Start the discussion