Allergic rhinoconjunctivitis with or without asthma due to sensitisation to Salsola kali pollen MedDRA version: 16.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AVANZ Salsola kali
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Salsola kali
Other descriptive name: SALSOLA KALI L.
Concentration unit: SQU/ml Standardised Quality
Sponsors
ALK-Abelló S. A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients 18-65 years of age. 2.A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. 3.Positive SPT to Salsola kali pollen (wheal diameter > 3 mm). 4.Documenting in the last 5 years a positive specific IgE against Salsola kali pollen (>=Class 2; >=0.70 KU/L). 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment. 2.Uncontrolled or severe asthma. 3.History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. 4.At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion). 5.Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). 6.Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis. 7.Immunotherapy with Salsola kali pollen extracts within the previous 5 years 8.Concomitant immunotherapy with any other allergen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of the up-dosing phase of AVANZ® Salsola kali. The frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.;Secondary Objective: Frequency of patients with systemic reactions according to EAACI classification for the investigational medicinal procuct. Increase in IgG4 and IgE for Salsola kali Reduction in immediate skin reactivity for Salsola kali;Primary end point(s): Incidence of adverse reactions to Salsola kali AVANZ® immunotherapy.;Timepoint(s) of evaluation of this end point: After up-dosing phase and one maintenance dose (6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in Salsola kali IgE and IgG4 levels from baseline to end of trial. Changes in immediate skin response to Salsola allergens from baseline to end of trial by parallel line assay.;Timepoint(s) of evaluation of this end point: After up-dosing phase and one maintenance dose (6 weeks) | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
ALK-Abelló S. A.
Outcome results
None listed