- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166268
Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber (AV-G-03)
January 25, 2016 updated by: ALK-Abelló A/S
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hannover, Germany, 30625
- Fraunhofer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 β-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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Avanz Phleum pratense
Avanz Phleum pratense 15,000 SQ+ (standardised quality), suspension for subcutaneous injection.
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Placebo Comparator: Placebo
Placebo, suspension for subcutaneous injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average total nasal symptom score
Time Frame: After 1-year of treatment
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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.
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After 1-year of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total nasal symptom score collected at the 2nd ECC visit
Time Frame: After 16 weeks of treatment
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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.
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After 16 weeks of treatment
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Average Total Symptom Score
Time Frame: Meaured after 16 weeks and 1 year of treatment.
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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
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Meaured after 16 weeks and 1 year of treatment.
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Treatment emergent adverse events
Time Frame: During the 1-year treatment period with Avanz
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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.
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During the 1-year treatment period with Avanz
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average nasal airflow
Time Frame: After 16 weeks and 1-year of treatment
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Average nasal airflow measured via active anterior rhinomanometry measured during the grass pollen challenge in the environmental challenge chamber.
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After 16 weeks and 1-year of treatment
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Average nasal secretion
Time Frame: After 16 weeks and 1-year of treatment
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Nasal secretion in pre-weighed handkerchiefs will be collected during each of the ECCs visits.
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After 16 weeks and 1-year of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens Hohlfeld, Prof., Fraunhofer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
June 11, 2014
First Submitted That Met QC Criteria
June 16, 2014
First Posted (Estimate)
June 18, 2014
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV-G-03
- 2013-005130-38 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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