PBASE System Idiopathic Rhinitis Clinical Investigation

September 8, 2014 updated by: Chordate Medical
The purpose of this study is to evaluate the performance of the PBASE system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Falun, Sweden
      • Gothenburg, Sweden
      • Lund, Sweden
      • Stockholm, Sweden
      • Västerås, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with persistent (>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
  • Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
  • Male or female 18 - 65 years
  • Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
  • Willing and able to provide written informed consent prior to participation in the clinical investigation
  • Willing and able to comply with all study related procedures

Exclusion Criteria:

  • Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST
  • Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
  • Systemic steroid treatment less than 4 weeks before the inclusion in the study
  • Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
  • History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
  • Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
  • Current malignancy of any kind
  • Known allergy to polyvinylchloride or medicinal liquid paraffin
  • Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk.
  • Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region.
  • Previous treated with radiation on the face, head or neck regions
  • Female patients who are pregnant or nursing, or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit
  • Female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit
  • Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PBASE system 1.1 + CT100 (active treatment)
Device: PBASE system 1.1 + CT100 (active treatment)
PLACEBO_COMPARATOR: PBASE system 1.1 + CT100 (placebo treatment)
Device: PBASE system 1.1 + CT100 (placebo treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total vasomotor rhinitis symptom score to visit 3
Time Frame: From baseline to 28 days after treatment visit 1
From baseline to 28 days after treatment visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chordate Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (ESTIMATE)

May 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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