Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PBASE System Idiopathic Rhinitis Clinical Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01844336
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Chordate Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Rhinitis Device: PBASE system 1.1 + CT100 (active treatment) Device: PBASE system 1.1 + CT100 (placebo treatment) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Primary Completion Date : August 2014

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)



Primary Outcome Measures :
  1. Change in total vasomotor rhinitis symptom score to visit 3 [ Time Frame: From baseline to 28 days after treatment visit 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01844336


Locations
Layout table for location information
Sweden
Falun, Sweden
Gothenburg, Sweden
Lund, Sweden
Stockholm, Sweden
Västerås, Sweden
Sponsors and Collaborators
Chordate Medical
Layout table for additonal information
Responsible Party: Chordate Medical
ClinicalTrials.gov Identifier: NCT01844336    
Other Study ID Numbers: PR003
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases