NCT02069535

Brief Summary

This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

February 18, 2014

Last Update Submit

January 5, 2015

Conditions

Allergic Rhinoconjunctivitis

Keywords

Cupressus arizonica

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients with IMP-related AEs

    6 treatment weeks

Secondary Outcomes (1)

  • Frequency of patients with systemic reactions

    6 weeks of treatment

Study Arms (1)

AVANZ Cupressus

EXPERIMENTAL

AVANZ Cupressus

Biological: AVANZ Cupressus

Interventions

AVANZ CupressusBIOLOGICAL

AVANZ Cupressus

AVANZ Cupressus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.
  • Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ≥ 3 mm)

You may not qualify if:

  • History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
  • Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
  • Ongoing treatment with any allergen-specific immunotherapy product.
  • A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).
  • A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario San Carlos

Madrid, Madrid, Spain

Location

Study Officials

  • Montserrat Fernández Rivas, PhD

    Hospital Clínico Universitario San Carlos, Madrid

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 24, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

ES(1)