Grazax Asthma Prevention (GAP)
This study is ongoing, but not recruiting participants.
Sponsor:
ALK-Abelló A/S
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01061203
First received: February 1, 2010
Last updated: August 27, 2012
Last verified: August 2012
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Purpose
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Grazax Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Grazax Asthma Prevention |
Resource links provided by NLM:
Further study details as provided by ALK-Abelló A/S:
Primary Outcome Measures:
- Evaluation of allergy and asthma symptoms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of life and adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Grazax
Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.
|
Drug: Grazax
Treatment with 75.000 SQ-T once daily
|
|
Placebo Comparator: Tablet with no active grass
Tablet with no active grass component. One tablet per day administered under the tongue.
|
Drug: Placebo
Tablet with no active grass component.
|
Detailed Description:
Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy.
Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.
Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A history of grass pollen allergy
- Positive Skin prick test to grass
- Positive specific IgE to grass
Exclusion Criteria:
- Asthma
Contacts and Locations More Information
No publications provided
| Responsible Party: | ALK-Abelló A/S |
| ClinicalTrials.gov Identifier: | NCT01061203 History of Changes |
| Other Study ID Numbers: | GT-21 |
| Study First Received: | February 1, 2010 |
| Last Updated: | August 27, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Norway: Norwegian Medicines Agency Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by ALK-Abelló A/S:
|
Rhinitis allergic Seasonal grass Asthma |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013