PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS
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|ClinicalTrials.gov Identifier: NCT01586468|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : April 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: WF10 Drug: NaCl Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||November 2010|
|Placebo Comparator: NaCl Solution||
Drug: NaCl Solution
|Experimental: WF10 0.5 ml/kg BW||
0.5 mg/kg B.W.
- TNSS [ Time Frame: 9 weeks ]
- MiniRQLQ score, POHA score, and rhinometric and spirometric parameters [ Time Frame: 9 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586468
|Leipzig, Sachsen, Germany, 04109|
|Principal Investigator:||Christian Gessner, M.D.||POIS|