Clinical trial NCT03112330: A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Rhinitis
Keywords: atrophic rhinitis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The change of mucociliary clearance function using the saccharin test
timeFrame: 2, 4, 8, 12, and 24th week
Secondary outcomes:
measure: The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument
timeFrame: 2, 4, 8, 12, and 24th week
measure: The change of nasal symptoms using the Sino-Nasal outcome Test 20
timeFrame: 2, 4, 8, 12, and 24th week
measure: The change of nasal symptoms using the Visual analog scale
timeFrame: 2, 4, 8, 12, and 24th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sung Won Kim, MD, PhD
role: STUDY_CHAIR
affiliation: Seoul St. Mary's Hospital
name: Do Hyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.