Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

This study has been completed.

Sponsor:

Information provided by:

Roxall Medizin

ClinicalTrials.gov Identifier:

NCT01012531

First received: November 11, 2009

Last updated: July 13, 2011

Last verified: November 2009

Purpose

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

Condition	Intervention	Phase
Allergic Rhinitis	Biological: Subcutaneous injections with highly polymerized allergen extract Biological: Subcutaneous injection with placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization

Further study details as provided by Roxall Medizin:

Primary Outcome Measures:

Symptom and medication score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety of the treatment during the study period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Documentation of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Global evaluation and Quality of life questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	October 2008
Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: highly polymerized allergen extract	Biological: Subcutaneous injections with highly polymerized allergen extract cluster schedule
Placebo Comparator: Placebo	Biological: Subcutaneous injection with placebo cluster schedule

Eligibility

Criteria

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012531

Locations

Germany
Zentrum für Rhinologie und Allergologie
Wiesbaden, Germany

Sponsors and Collaborators

Roxall Medizin

More Information

No publications provided

Responsible Party:	Jenny Uhlig, Roxall Medizin
ClinicalTrials.gov Identifier:	NCT01012531 History of Changes
Other Study ID Numbers:	CLU-2008-001
Study First Received:	November 11, 2009
Last Updated:	July 13, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013