Grass Pollen Induced Allergic Rhinoconjunctivitis Clinical Trial
— AV-G-03Official title:
Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber
| Verified date | January 2016 |
| Source | ALK-Abelló A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics CommissionGermany: Paul-Ehrlich-Institut |
| Study type | Interventional |
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Written informed consent - Male or female aged 18 to 65 years - The subject fulfills one of the following criteria: - Male - Female, infertile - Female of child-bearing potential, with a negative pregnancy test - Moderate-to-severe grass pollen induced rhinoconjunctivitis - Positive skin prick test response (wheal diameter = 3 mm) to Phleum pratense - Positive specific Immunoglobulin E (IgE) against Phleum pratense (= IgE Class 2; =0.70 kilo Unit/L) - Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a total nasal symptom score of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit - The subject must be willing and able to comply with the trial protocol Exclusion Criteria: - Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate - Rhinoconjunctivitis caused by animal hair and dander, house dust mites and moulds - Clinical history of uncontrolled asthma within 3 months prior to screening - Subjects with reduced lung function forced expiratory volume in 1 second <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 - Ongoing treatment with any allergen-specific immunotherapy product - Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation and at the baseline challenge - Clinically relevant nasal polyps - History of paranasal sinus surgery - History of surgery of nasal turbinates - History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction) - History of recurrent (defined as 2 or more episodes) generalised urticaria during the last 2 years - History of drug-induced (including immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema - Any clinically relevant chronic disease (=3 months duration) (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subjects) - Systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease) - Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit - Currently treated with tricyclic antidepressants, catecholamine-O - methyltransferase inhibitors and/or mono amine oxidase inhibitors - Treatment with antidepressant medication with antihistaminic effect (e.g. doxepin, mianserin) - Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, thioridazine) - Treatment with anti-IgE drugs (e.g. omalizumab) within 130 days/5 half-lives which ever longest - Treatment with systemic and/or topical ß-blockers - Use of an investigational drug within 30 days/5 half-lives of the drug, which ever the longest, prior to screening - History of allergy, hypersensitivity or intolerance to an excipient the investigational drug (except Phleum pratense) - Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild - History of alcohol or drug abuse |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Fraunhofer Institute | Hannover |
| Lead Sponsor | Collaborator |
|---|---|
| ALK-Abelló A/S |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Average nasal airflow | Average nasal airflow measured via active anterior rhinomanometry measured during the grass pollen challenge in the environmental challenge chamber. | After 16 weeks and 1-year of treatment | No |
| Other | Average nasal secretion | Nasal secretion in pre-weighed handkerchiefs will be collected during each of the ECCs visits. | After 16 weeks and 1-year of treatment | No |
| Primary | Average total nasal symptom score | The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the final Environmental challenge chamber (ECC) visit. | After 1-year of treatment | No |
| Secondary | Total nasal symptom score collected at the 2nd ECC visit | The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the 2nd ECC visit. | After 16 weeks of treatment | No |
| Secondary | Average Total Symptom Score | The total symptom score consist of 4 nasal symptoms and 2 eye symptoms measured on a scale from 0-3. Measured during the 2nd and the final ECC visit | Meaured after 16 weeks and 1 year of treatment. | No |
| Secondary | Treatment emergent adverse events | Adverse events (AE) will be collected during the trial. AEs will be summaries by treatment group, Medical Dictionary for Regulatory Activities (MedDRA) system organ class, preferred term and broken down by severity, seriousness, action taken, dosing step and outcome. An analysis of local and systemic reactions and AEs leading to discontinuation. An analysis of early and delayed reactions after the treatment will further be performed. | During the 1-year treatment period with Avanz | Yes |