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A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis (ARPRP)

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: NCT03112330
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sung Won Kim, Seoul St. Mary's Hospital

Brief Summary:

The goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa.

Specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.


Condition or disease Intervention/treatment Phase
Atrophic Rhinitis Device: Plasma rich platelet injection Device: Saline nasal spray Not Applicable

Detailed Description:

Clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa.

  • Injection interval and follow-up duration

    • Injection interval 2 weeks (upto total 3 consecutive injection)
    • Follow-up duration: 6 months
  • Observation items, clinical assessment items and evaluation method

    • Access the nasal mucosal status using nasal speculum.
    • Access the nasal mucociliary function using saccharin test (primary outcome; once per month).
    • Fill in the nasal symptom scores using Nasal Obstruction Symptom Evaluation(NOSE) Instrument, Sino-Nasal outcome Test 20, and Visual analog scale (secondary outcome; once per month)
  • The other atrophic rhinitis patients who did not want to perform platelet rich plasma injection

    • Random allocation to saline nasal irrigation or saline nasal spray group
    • Perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Patients With Atrophic Rhinitis
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Arm Intervention/treatment
Experimental: platelet rich plasma injection group
To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
Device: Plasma rich platelet injection
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa

Device: Saline nasal spray
two puffs of isotonic saline nasal spray twice daily




Primary Outcome Measures :
  1. The change of mucociliary clearance function using the saccharin test [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment


Secondary Outcome Measures :
  1. The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment

  2. The change of nasal symptoms using the Sino-Nasal outcome Test 20 [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment

  3. The change of nasal symptoms using the Visual analog scale [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (>18 years)
  • Complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip
  • Atrophic rhinitis view on nasal endoscopic finding
  • Patients who informed sufficient about other atrophic rhinitis treatment options including Young's operation, lubricants, or saline irrigation, but, want more other active treatment option.

Exclusion Criteria:

  • Platelet related disorders
  • Low serum platelet (<100,000/㎕)
  • Other hematologic disorders
  • Septicemia
  • Take anticoagulant drugs

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): NCT03112330


Locations
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Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
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Study Chair: Sung Won Kim, MD, PhD Seoul St. Mary's Hospital
Principal Investigator: Do Hyun Kim, MD, PhD Seoul St. Mary's Hospital
Publications:

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Responsible Party: Sung Won Kim, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03112330    
Other Study ID Numbers: CMCENT-01
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sung Won Kim, Seoul St. Mary's Hospital:
atrophic rhinitis
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Atrophic
Atrophy
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical