A Phase III trial evaluating the tolerability of Grazax treatment in combination with antihistamine in subjects with seasonal grass pollen induced rhinoconjunctivitis

Conditions: Grass pollen induced rhinoconjunctivitis
MedDRA version: 9.1Level: LLTClassification code 10039097Term: Rhinoconjunctivitis

Registration Number: EUCTR2008-003593-18-DE

Lead Sponsor: ALK-Abelló A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season.
2. Reporting of treatment related allergic adverse events (local reactions in mouth and throat) after intake of Grazax at screening (visit 1).
3. Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm larger than the negative control with a flare) to Phleum pratense.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Uncontrolled asthma in the past 12 months
2. FEV1 < 70% of predicted value (calculated according to (21))
3. A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which may cause symptoms during the conduct of this trial
4. A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject is regularly exposed
5. At randomisation, 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)
6. History of emergency visit or admission for asthma in the previous 12 months
7. History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
8. History of allergy, hypersensitivity or intolerance to IMPs (except for Phleum pratense) or Desloratadine

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is 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.<br><br>;Secondary Objective: None.;Primary end point(s): The primary endpoint is reduction in number of subjects reporting AEs during treatment with Grazax in combination with Aerius compared to treatment with Grazax in combination with placebo.

Secondary Outcome Measures