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PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS

NCT01586468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-04-26

No results posted yet for this study

Summary

Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects with persistent allergic rhinitis.

Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre trial.

Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS) (mean score of morning and evening reflective TNSS assessments for the 3 days prior to randomization and treatment.

Treatments At the first treatment visit (T1), subjects that comply with the inclusion and exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.

Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into 500 mL saline solution. Treatment will be administered once daily for 5 consecutive days (Visits T1-T5) via intravenous infusion.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

WF10

0.5 mg/kg B.W.

DRUG

NaCl Solution

NaCl Solution

Sponsors & Collaborators

  • Nuvo Research GmbH

    lead INDUSTRY

Principal Investigators

  • Christian Gessner, M.D. · POIS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586468 on ClinicalTrials.gov