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

Primary Purpose

Atrophic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Plasma rich platelet injection
Saline nasal spray
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Rhinitis focused on measuring atrophic rhinitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

platelet rich plasma injection group

Arm Description

To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis

Outcomes

Primary Outcome Measures

The change of mucociliary clearance function using the saccharin test
The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment

Secondary Outcome Measures

The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument
The change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment
The change of nasal symptoms using the Sino-Nasal outcome Test 20
The change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment
The change of nasal symptoms using the Visual analog scale
The change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment

Full Information

First Posted
April 4, 2017
Last Updated
April 2, 2019
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03112330
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis
Acronym
ARPRP
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Rhinitis
Keywords
atrophic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet rich plasma injection group
Arm Type
Experimental
Arm Description
To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
Intervention Type
Device
Intervention Name(s)
Plasma rich platelet injection
Intervention Description
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Intervention Type
Device
Intervention Name(s)
Saline nasal spray
Intervention Description
two puffs of isotonic saline nasal spray twice daily
Primary Outcome Measure Information:
Title
The change of mucociliary clearance function using the saccharin test
Description
The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment
Time Frame
2, 4, 8, 12, and 24th week
Secondary Outcome Measure Information:
Title
The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument
Description
The change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment
Time Frame
2, 4, 8, 12, and 24th week
Title
The change of nasal symptoms using the Sino-Nasal outcome Test 20
Description
The change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment
Time Frame
2, 4, 8, 12, and 24th week
Title
The change of nasal symptoms using the Visual analog scale
Description
The change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment
Time Frame
2, 4, 8, 12, and 24th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Won Kim, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Do Hyun Kim, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24938860
Citation
Friji MT, Gopalakrishnan S, Verma SK, Parida PK, Mohapatra DP. New regenerative approach to atrophic rhinitis using autologous lipoaspirate transfer and platelet-rich plasma in five patients: Our Experience. Clin Otolaryngol. 2014 Oct;39(5):289-92. doi: 10.1111/coa.12269. No abstract available.
Results Reference
background
PubMed Identifier
15085519
Citation
Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
Results Reference
background
PubMed Identifier
20878413
Citation
Hildenbrand T, Weber RK, Brehmer D. Rhinitis sicca, dry nose and atrophic rhinitis: a review of the literature. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):17-26. doi: 10.1007/s00405-010-1391-z. Epub 2010 Sep 29.
Results Reference
background
PubMed Identifier
22336840
Citation
Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD008280. doi: 10.1002/14651858.CD008280.pub2.
Results Reference
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PubMed Identifier
18317788
Citation
Jaswal A, Jana AK, Sikder B, Nandi TK, Sadhukhan SK, Das A. Novel treatment of atrophic rhinitis: early results. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1211-7. doi: 10.1007/s00405-008-0629-5. Epub 2008 Mar 4.
Results Reference
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PubMed Identifier
21679513
Citation
Modrzynski M. Hyaluronic acid gel in the treatment of empty nose syndrome. Am J Rhinol Allergy. 2011 Mar-Apr;25(2):103-6. doi: 10.2500/ajra.2011.25.3577.
Results Reference
background
PubMed Identifier
3237448
Citation
Canciani M, Barlocco EG, Mastella G, de Santi MM, Gardi C, Lungarella G. The saccharin method for testing mucociliary function in patients suspected of having primary ciliary dyskinesia. Pediatr Pulmonol. 1988;5(4):210-4. doi: 10.1002/ppul.1950050406.
Results Reference
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PubMed Identifier
27938467
Citation
Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. doi: 10.1017/S0022215116009403.
Results Reference
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A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis

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