Grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: 5-grass mix SLIT-drops
Pharmaceutical Form: Oral solution in single-dose container
INN or Proposed INN: DACTYLIS GLOMERATA L.
Other descriptive name: cat grass /cock's foot/orchard grass
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Written informed consent obtained before any trial related procedures are performed I2. Male or female aged =18 years on the day informed consent is obtained I3. For female subjects of childbearing potential, a negative pregnancy test and willingness to practice appropriate contraceptive methods until the follow-up visit must be confirmed I4. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma I5. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season I6. Positive specific immunoglobulin E (IgE) (defined as =class 2, =0.70 kU/l) against grass: Phleum pratense I7. Positive skin prick test (SPT) to Phleum pratense at screening I8. The subject must be willing and able to comply with the trial protocol 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 440 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: E1. Previous participation in this trial. Participation is defined as screening E2. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods E3. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids E4. Reduced lung function: FEV1 <70% of predicted value after adequate pharmacologic treatment E5. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months E6. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months E7. Ongoing treatment with any allergy immunotherapy product E8. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening E9. Severe chronic oral inflammation E10. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g. hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates) E11. Has a diagnosis of eosinophilic oesophagitis E12. 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) E13. A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern E14. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject E15. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance E16. Immunosuppressive treatment (ATC code L04 or L01) = 90 days prior to the screening visit E17. Treatment with medications with potential impact on efficacy endpoints (e.g. treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminic effect) E18. A history of allergy, hypersensitivity or intolerance to the IMP (except to the active ingredient) or any of the background treatment provided in this trial E19. Female who is pregnant or breast-feeding E20. Has a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of 5-grass mix SLIT-drops to placebo in relieving grass rhinoconjunctivitis symptoms and in use of symptom-relief medication during the 2nd Peak Grass Pollen Season (PGPS);Secondary Objective: • To measure the impact of treatment with 5-grass mix SLIT-drops compared to placebo on health-related quality of life as a result of grass pollen-induced rhinoconjunctivitis during the 2nd PGPS • To compare the efficacy of 5-grass mix SLIT-drops to placebo in relieving grass rhinoconjunctivitis symptoms and in use of symptom-relief medication during the 1st PGPS • To measure the impact of treatment with 5-grass mix SLIT-drops compared with placebo on health-related quality of life as a result of their grass pollen-induced rhinoconjunctivitis during the 1st PGPS;Primary end point(s): The primary efficacy endpoint is the average daily allergic rhinoconjunctivitis TCS during the 2nd PGPS;Timepoint(s) of evaluation of this end point: Date of the last data collection for the primary endpoint (ClinicalTrials.gov) is the last scheduled physical visit for any subject (visit 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The average weekly overall rhinitis quality of life questionnaire (RQLQ) score during the 2nd PGPS • The average daily allergic rhinoconjunctivitis TCS during the 1st PGPS • The average weekly overall RQLQ score during the 1st PGPS;Timepoint(s) of evaluation of this end point: • The average weekly overall rhinitis quality of life questionnaire (RQLQ) score during the 2nd PGPS • The average daily allergic rhinoconjunctivitis TCS during the 1st PGPS • The average weekly overall RQLQ score during the 1st PGPS | — |
Countries
Czech Republic, Latvia, Lithuania
Contacts
Public ContactSenior Director
ALK-Abelló A/S
Outcome results
None listed