NCT01586468

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS

Completed Phase 2 Last updated 25 April 2012

What this trial tests

Phase 2 trial testing WF10 in Allergic Rhinitis in 60 participants. Completed in 1 November 2010.

Timeline

1 March 2010

Primary endpoint
1 September 2010

1 November 2010

Quick facts

Lead sponsor	Nuvo Research GmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2010
Primary completion	1 September 2010
Estimated completion	1 November 2010
Sites	1 location across Germany

Drugs / interventions tested

• WF10 — full drug profile →
• NaCl Solution

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Nuvo Research GmbH

Who can join

Adults 18 to 70, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• TNSS
  Time frame: 9 weeks

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.