Atrophic RhinitisARPRPNCT03112330
A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis
A study testing Plasma rich platelet injection and Saline nasal spray in people with Atrophic Rhinitis, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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 . Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrophic Rhinitis
- What is being tested?
- Plasma rich platelet injection and Saline nasal spray
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Platelet related disorders
- Low serum platelet (<100,000/㎕)
- Other hematologic disorders
- Septicemia
- Take anticoagulant drugs
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Atrophic Rhinitis
- Being tested
- Plasma rich platelet injection, Saline nasal spray
- Keywords
- atrophic rhinitis
- Medical subject headings
- Rhinitis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma rich platelet injectionDevice
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Saline nasal sprayDevice
two puffs of isotonic saline nasal spray twice daily
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma injection group | Experimental | To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis Receives: Device: Plasma rich platelet injection; Device: Saline nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2, 4, 8, 12, and 24th week
Secondary outcomes (3)
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
Measured: 2, 4, 8, 12, and 24th week
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
Measured: 2, 4, 8, 12, and 24th week
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
Measured: 2, 4, 8, 12, and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start8 Jun 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrophic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Won Kim, Seoul St. Mary's Hospital
- Investigators
- Sung Won Kim, MD, PhD, Study chair, Seoul St. Mary's HospitalDo Hyun Kim, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112330
- Sponsor's protocol ID
- CMCENT-01
- Acronym
- ARPRP
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24938860Marx 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.
PubMed 15085519Hildenbrand 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.
PubMed 20878413Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008280. doi: 10.1002/14651858.CD008280.pub2.
PubMed 22336840Jaswal 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.
PubMed 18317788Modrzynski 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.
PubMed 21679513Canciani 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.
PubMed 3237448Stavrakas 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.
PubMed 27938467
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03112330
- Acronym / sponsor ID
- ARPRP / CMCENT-01
- Conditions
- Atrophic Rhinitis
- Keywords
- atrophic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma injection group | Experimental | Device: Plasma rich platelet injection, Device: Saline nasal sprayTo evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Platelet related disorders
- Low serum platelet (<100,000/㎕)
- Other hematologic disorders
- Septicemia
- Take anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma rich platelet injectionPlasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa | Device | platelet rich plasma injection group |
| Saline nasal spraytwo puffs of isotonic saline nasal spray twice daily | Device | platelet rich plasma injection group |
Primary outcome
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
3 secondary outcomes
The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument
Time frame: 2, 4, 8, 12, and 24th week
The change of nasal symptoms using the Sino-Nasal outcome Test 20
Time frame: 2, 4, 8, 12, and 24th week
The change of nasal symptoms using the Visual analog scale
Time frame: 2, 4, 8, 12, and 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 24938860Friji 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.
- Background: PubMed 15085519Marx 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.
- Background: PubMed 20878413Hildenbrand 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.
- Background: PubMed 22336840Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008280. doi: 10.1002/14651858.CD008280.pub2.
- Background: PubMed 18317788Jaswal 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.
- Background: PubMed 21679513Modrzynski 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.
- Background: PubMed 3237448Canciani 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.
- Background: PubMed 27938467Stavrakas 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Kim, MD, PhD study chair
Seoul St. Mary's Hospital
Do Hyun Kim, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma rich platelet injection and Saline nasal spray in people with Atrophic Rhinitis, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of mucociliary clearance function using the saccharin test (time frame: 2, 4, 8, 12, and 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112330, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.