A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine

Allergic Rhinoconjunctivitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740284
• Other study ID #: GT-19
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2012
• Last updated: February 7, 2013
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2013
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Grazax + Aerius

• Grazax + placebo

Locations

Country	Name	City	State
Germany	Zentrum für Rhinologie und Allergologie	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		28 days following the first dosing	Yes
Secondary	Other safety endpoint	Vitals signs measured three times (Day 0, Day 14 and Day 28)	28 days following first dosing	Yes
Secondary	Other safety endpoint	FEV1 measured three times (Day 0, Day 14 and Day 28)	28 Days following the first dosing	Yes