Back to resultsA Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine (GT-19)
Primary Purpose
Allergic Rhinoconjunctivitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Grazax + Aerius
Grazax + placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Male or female 18-65 years of age
- Written informed consent obtained before any clinical trial procedures are performed
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- Reporting of treatment related allergic AEs (local reactions in mouth and throat) after intake of Grazax at screening (visit 1)
- Positive skin prick test (SPT) response (wheal diameter ≥ 3 mm larger than the negative control with a flare) to Phleum pratense
- Female subjects had to be non-pregnant and non-lactating.
- Subject willing and able to comply with the protocol
Exclusion Criteria:
- Uncontrolled asthma in the past 12 months
- FEV1 < 70% of predicted value (calculated according to ECCS (20))
- A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which might have caused symptoms during the conduct of this trial
- A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject was regularly exposed
- At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
- History of emergency visit or admission for asthma in the previous 12 months
- Use of an investigational drug within 30 days prior to screening
- History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
- History of chronic urticaria within the last year
- History of angioedema
- Any of the following underlying conditions known or suspected to be present:
- Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal, or hepatic insufficiency, chronic infection, drug dependency or alcoholism
- Any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric and ongoing long term treatment with tranquilizer or psychoactive drugs, endocrine, or other major systemic disease or malignancies (including auto-immune diseases, tuberculosis and HIV)).
- Immunosuppressive treatment
- History of allergy, hypersensitivity or intolerance to IMPs (except for Phleum pratense) or desloratadine
- Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the trial, which in the opinion of the investigator will compromise the data
- Being the investigator, trial staff or their immediate families, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild or being the 2nd member of a family (living in the same household)
- Use of any prohibited drugs
Sites / Locations
- Zentrum für Rhinologie und Allergologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Grazax + Aerius
Grazax + Placebo
Arm Description
1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (desloratidine) 2.5 mg
1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (Placebo)
Outcomes
Primary Outcome Measures
To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure
Secondary Outcome Measures
Other safety endpoint
Vitals signs measured three times (Day 0, Day 14 and Day 28)
Other safety endpoint
FEV1 measured three times (Day 0, Day 14 and Day 28)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01740284
Brief Title
A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
Acronym
GT-19
Official Title
A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment.
The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
Detailed Description
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The adverse events are considered consistent with the introduction of allergens in sensitised subjects. The majority are local allergic reactions within the mouth and/or throat. Most of these reactions are mild or moderate in intensity, have an onset almost immediately after taking a tablet, and last from minutes to hours after intake. Appearance of adverse events in relation to tablet intake tends to subside spontaneously within 1 to 7 days. Thus, initiation of treatment with Grazax may be associated with discomfort. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. Therefore, the rationale for this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grazax + Aerius
Arm Type
Active Comparator
Arm Description
1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (desloratidine) 2.5 mg
Arm Title
Grazax + Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T and 1 tablet (melting tablet)of Aerius (Placebo)
Intervention Type
Drug
Intervention Name(s)
Grazax + Aerius
Intervention Type
Drug
Intervention Name(s)
Grazax + placebo
Primary Outcome Measure Information:
Title
To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure
Time Frame
28 days following the first dosing
Secondary Outcome Measure Information:
Title
Other safety endpoint
Description
Vitals signs measured three times (Day 0, Day 14 and Day 28)
Time Frame
28 days following first dosing
Title
Other safety endpoint
Description
FEV1 measured three times (Day 0, Day 14 and Day 28)
Time Frame
28 Days following the first dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 18-65 years of age
Written informed consent obtained before any clinical trial procedures are performed
A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
Reporting of treatment related allergic AEs (local reactions in mouth and throat) after intake of Grazax at screening (visit 1)
Positive skin prick test (SPT) response (wheal diameter ≥ 3 mm larger than the negative control with a flare) to Phleum pratense
Female subjects had to be non-pregnant and non-lactating.
Subject willing and able to comply with the protocol
Exclusion Criteria:
Uncontrolled asthma in the past 12 months
FEV1 < 70% of predicted value (calculated according to ECCS (20))
A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which might have caused symptoms during the conduct of this trial
A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject was regularly exposed
At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion)
History of emergency visit or admission for asthma in the previous 12 months
Use of an investigational drug within 30 days prior to screening
History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
History of chronic urticaria within the last year
History of angioedema
Any of the following underlying conditions known or suspected to be present:
Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal, or hepatic insufficiency, chronic infection, drug dependency or alcoholism
Any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric and ongoing long term treatment with tranquilizer or psychoactive drugs, endocrine, or other major systemic disease or malignancies (including auto-immune diseases, tuberculosis and HIV)).
Immunosuppressive treatment
History of allergy, hypersensitivity or intolerance to IMPs (except for Phleum pratense) or desloratadine
Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the trial, which in the opinion of the investigator will compromise the data
Being the investigator, trial staff or their immediate families, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild or being the 2nd member of a family (living in the same household)
Use of any prohibited drugs
Facility Information:
Facility Name
Zentrum für Rhinologie und Allergologie
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
12. IPD Sharing Statement
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A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
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