NCT01014325

Brief Summary

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

November 11, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
6.8 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 11, 2009

Last Update Submit

November 2, 2015

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Symptom and medication score

    1 year

Secondary Outcomes (4)

  • Safety of sublingual application

    1 year

  • Protocol of adverse events

    1 year

  • Quality of Life Questionnaire

    1 year

  • Evaluation of patients' related clinical global improvement

    1 year

Study Arms (2)

Allergen extract

EXPERIMENTAL
Biological: Allergen extract

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Allergen extractBIOLOGICAL

sublingual application

Allergen extract
PlaceboBIOLOGICAL

sublingual application

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive history of perennial allergic rhinitis
  • Positive screening skin prick test (wheal diameter \> 3 mm)
  • Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
  • Signed and dated patient´s Informed Consent,

You may not qualify if:

  • Previous immunotherapy with allergen extracts within the last 3 years,
  • Simultaneous participation in other clinical trials,
  • Auto-immune disorders,
  • Severe chronic inflammatory diseases,
  • Malignancy,
  • Alcohol abuse,
  • Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
  • Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madrid, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Central Study Contacts

Roxall Medizin

CONTACT

+49408972520

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

November 11, 2009

First Posted

November 16, 2009

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

ES(1)