A randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two doses of oral microencapsulated grass pollen extract administered prior to and during the the grass pollen seaso

Phase 1

• Conditions: Seasonal rhino-conjunctivitis due to grass pollen allergy; MedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis

• Registration Number: EUCTR2007-003345-33-FR
• Lead Sponsor: Curalogic A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-30
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

Have signed the informed consent.
Have a history of two consecutive seasons of moderate to severe seasonal allergic rhinitis in the period May to July that has required repeated treatment e.g. antihistamines, leukotriene antagonists, nasal steroids and topical cromones.
Have a positive skin prick test to a standardised grass pollen extract (diameter of the wheal must be the same size as the positive control and longest diameter 5mm)
Have a grass specific IgE level of at least 0.7kU/L using the Phadia ImmunoCAP assay.
Have a positive nasal provocation test.
Will be available for clinic visits for the duration of the study.
Aged 18-65.
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

Are pregnant and/or breastfeeding
Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk.
Have moderate to severe perennial or structurally related rhinitis, including vasomotor rhinitis.
Have a routine sleeping pattern between the hours of approximately 6.00am to 6.00pm (i.e. night workers).
Are currently receiving immunotherapy to any allergens and/or have received grass immunotherapy within 3 years of the Screening Visit.
Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced FEV1<70% of the predicted value despite treatment with asthma medication.
Have moderate to severe persistent asthma (GINA criteria III and IV).
Will travel outside a grass pollen region during the grass pollen season (May 1-July 15) for more than 3 consecutive days or for more than a total of 7 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified