Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber

NCT02166268 | Completed Phase 2

• 2 other identifiers: AV-G-032013-005130-38
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.

Conditions

Grass Pollen Induced Allergic Rhinoconjunctivitis

Keywords

Allergic rhinoconjunctivitis; Allergic rhinitis; Allergy; Grass pollen

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Total nasal symptom score collected at the 2nd ECC visit

  After 16 weeks of treatment

• Average Total Symptom Score

  Meaured after 16 weeks and 1 year of treatment.

• Treatment emergent adverse events

  During the 1-year treatment period with Avanz

Other Outcomes (2)

• Average nasal airflow

  After 16 weeks and 1-year of treatment

• Average nasal secretion

  After 16 weeks and 1-year of treatment

Study Arms (2)

Avanz Phleum pratense

ACTIVE COMPARATOR

Avanz Phleum pratense 15,000 SQ+ (standardised quality), suspension for subcutaneous injection.

Drug: AVANZ Phleum pratense 15,000 SQ+

Placebo

PLACEBO COMPARATOR

Placebo, suspension for subcutaneous injection.

Drug: Placebo

Interventions

AVANZ Phleum pratense 15,000 SQ+ DRUG

Avanz Phleum pratense

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Fraunhofer Institute

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Jens Hohlfeld, Prof.

  Fraunhofer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

DE (1)