Evaluation of the efficacy and safety of AVANZ® Phleum pratense in grass pollen-induced allergic rhinitis during controlled exposure in an environmental challenge chamber

Conditions: Seasonal grass pollen induced allergic rhino-conjunctivitis with or without asthma.
MedDRA version: 17.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-005130-38-DE

Lead Sponsor: ALK-Abello A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

A documented clinically relevant history of moderate-to-severe grass pollen induced rhinoconjunctivitis with or without asthma despite having received treatment with symptom relieving medication during the previous two grass pollen seasons
Positive SPT response (wheal diameter = 3 mm) to Phleum pratense at screening
Positive specific IgE against Phleum pratense (= IgE Class 2; =0.70 kU/L) at screening
Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a TNSS of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit

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 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate, . Subjects sentised to ragweed, mugwort or Alternaria alternate are not eligible for the trial if they have symptoms induced by these allergens
Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed. Subjects sensitised to perennial allergens such as house dust mites, and moulds are not eligible for the trial if they have symptoms induced by these allergens
Clinical history of uncontrolled asthma within 3 months prior to screening
Subjects with reduced lung function FEV1 <70% of the predicted value after adequate pharmacologic treatment
Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
Previous treatment with immunotherapy to a grass pollen allergen or a cross-reacting allergen within the past 5 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of AVANZ® Phleum pratense 15000 SQ+ compared to placebo in the treatment of grass pollen-induced allergic rhinitis using a Environmental Challenge Chamber.<br>;Secondary Objective: To evaluate;<br>The safety and tolerability of AVANZ® Phleum pratense 15000 SQ+ compared to placebo.<br>Changes in immunological parameters.<br>The efficacy of AVANZ® Phleum pratense 15000 SQ+ during treatment.<br>;Primary end point(s): The primary efficacy endpoint is the average Total Nasal Symptom Score (TNSS) measured after end of treatment with AVANZ compared to placebo.<br>;Timepoint(s) of evaluation of this end point: After approximately 11 months of treatment with AVANZ

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: During and after treatment with AVANZ.;Secondary end point(s): Changes in immunological parameters during and after treatment with AVANZ.<br>Adverse Events during treatment with AVANZ.<br>Average Total Nasal Symptom Score (TNSS) measured during treatment with AVANZ compared to placebo.<br>Average Total Nasal and Eye Symptom Score measured during and after treatment with AVANZ compared to placebo.<br><br><br><br><br>