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

• Sponsor: Seoul St. Mary's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03112330
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Rhinitis	Device: Plasma rich platelet injection; Device: Saline nasal spray	N/A

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

Study Design

• Study Type: Interventional
• 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 anticipatedPlatelet 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: Jun 8, 2017
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of mucociliary clearance function using the saccharin test [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591

Sponsors and Collaborators

• Seoul St. Mary's Hospital

Investigators

• Study Chair: Sung Won Kim, MD, PhD, Seoul St. Mary's Hospital
• Principal Investigator: Do Hyun Kim, MD, PhD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.
• 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.
• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review.
• 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. Review.
• Modrzyński 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.
• Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. Review.

• Responsible Party: Sung Won Kim, Professor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT03112330
• Other Study ID Numbers: CMCENT-01
• First Posted: Apr 13, 2017
• Last Update Posted: Apr 4, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sung Won Kim, Professor, Seoul St. Mary's Hospital: atrophic rhinitis
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Atrophic; Atrophy

Study Results

No Results Posted as of Apr 4, 2019