A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine

NCT01740284 | Completed Phase 3

• 1 other identifier: GT-19
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Other safety endpoint

  28 days following first dosing

• Other safety endpoint

  28 Days following the first dosing

Study Arms (2)

Grazax + Aerius

ACTIVE COMPARATOR

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

Drug: Grazax + Aerius

Grazax + Placebo

PLACEBO COMPARATOR

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)

Drug: Grazax + placebo

Interventions

Grazax + Aerius DRUG

Grazax + Aerius

Grazax + placebo DRUG

Grazax + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Zentrum für Rhinologie und Allergologie

Wiesbaden, 65183, Germany

Location

MeSH Terms

Interventions

Grazax; desloratadine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

DE (1)