NCT00916760

Brief Summary

The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 11, 2013

Status Verified

August 1, 2012

Enrollment Period

5 years

First QC Date

June 8, 2009

Last Update Submit

November 8, 2013

Conditions

Allergic Rhinoconjunctivitis

Keywords

allergic, rhinoconjunctivitis, Immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Symptoms score

    2 years

Secondary Outcomes (1)

  • Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization

    2 years

Study Arms (2)

1

EXPERIMENTAL

A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.

Biological: Depigoid Parietaria judaica 1000DPP/ml

2

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Depigoid Parietaria judaica 1000DPP/mlBIOLOGICAL

Subcutaneous monthly treatment

Also known as: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.
1
PlaceboBIOLOGICAL

Subcutaneous monthly treatment

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent, signed by the subject
  • Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
  • Patient of both gender aged from 18 up to 55
  • Diagnosed Sensitivity to Parietaria pollen base on:
  • Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica \>0,7KU/L
  • \- Patients who are able to comply with the dose regime

You may not qualify if:

  • Relevant sensitivity to another perenne allergen
  • Patient with asthma
  • Use of immunotherapy during the last four years
  • Treatment with B. Blocking agents
  • Patient suffering from some pathology in which adrenaline was contraindicated
  • Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
  • Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
  • Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance.
  • Intolerance to aspirin
  • Pregnant women or with pregnancy risk and brest-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

H. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Viladecans

Barcelona, Barcelona, 08840, Spain

Location

Hospital Vega Baja

Alicante, Orihuela, 03314, Spain

Location

H. de sagunto

Sagunto, Sagunto, 46520, Spain

Location

Hospital General de Onteniente

Ontinyent, Valencia, Spain

Location

Hospital Luis Alcañiz

Xàtiva, Valencia, Spain

Location

Hospital Marina Baixa

Alicante, Spain

Location

Hospital de Castellón

Castellon, Spain

Location

Hospital Reina Sofía

Murcia, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Study Officials

  • Angel Ferrer, Dr

    Hospital Vega Baja

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

February 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 11, 2013

Record last verified: 2012-08

Locations

ES(11)