NCT04167085: NOSTRIL

NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial

Completed Phase 4 Results posted Last updated 20 July 2022

What this trial tests

Phase 4 trial testing Doxycycline in Epistaxis in 26 participants. Completed in 1 June 2021.

Timeline

18 December 2017

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	26
Start date	18 December 2017
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Doxycycline (doxycycline) — full drug profile →
• Placebo

Conditions studied

• Epistaxis — all drugs for Epistaxis →

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Epistaxis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Epistaxis Primary · Baseline, post-washout - approximately 6 months

Change in number of bleeding episodes per week by participant self-report via nosebleed diary

Group	Value	95% CI
Doxycycline	-1.68	± 6.55
Placebo	1.14	± 4.44

Duration of Epistaxis Primary · Baseline, post-washout - approximately 6 months

Change in duration of bleeding per week by patient self-report via nosebleed diary

Group	Value	95% CI
Doxycycline	-41.17	± 159.26
Placebo	24.36	± 58.03

Change in Severity of Epistaxis Primary · Baseline, post-washout - approximately 6-months

Epistaxis Severity Scale (ESS) for Hereditary Hemorrhagic Telangiectasia, is based on 6 nosebleed variables such as frequency and duration which are reported by patients.The ESS has a minimum value of 0 and maximum value of 10, with 10 representing more severe epistaxis.

Group	Value	95% CI
Doxycycline	-.095	± 1.55
Placebo	-0.32	± 1.3

Change in Quality of Life Secondary · Baseline, post-washout - approximately 6 months

The 12-item Short Form (SF-12) is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5-point Likert scale and 2 are answered on a 3-point Likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health.

SF-12 Physical

Group	Value	95% CI
Doxycycline	2.21	± 6.94
Placebo	-0.83	± 6.72

SF-12 Mental

Group	Value	95% CI
Doxycycline	-0.63	± 9.97
Placebo	-0.63	± 9.74

Change in Ferritin Level Secondary · Baseline, post-washout - approximately 6 months

Group	Value	95% CI
Doxycycline	14.9	± 72.82
Placebo	-47.4	± 214.83

Change in Hemoglobin Level Secondary · Baseline, post-washout (approximately 6 months)

Group	Value	95% CI
Doxycycline	0.26	± 1.09
Placebo	-0.12	± 1.19

Change in Monthly Units of Packed Red Blood Cells (PRBCs) Transfused Secondary · Baseline, post-washout (approximately 6 months)

Group	Value	95% CI
Doxycycline	0	± 0.31
Placebo	0	± 0

Incidence of Treatment Failure Secondary · Baseline, post-washout (approximately 6 months)

Treatment failure, defined as need for nasal surgery or other epistaxis treatments

Group	Value	95% CI
Doxycycline	0
Placebo	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, post-washout (approximately 6 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Doxycycline

Serious: 0/23 (0%)

Deaths: 0/23

Placebo

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (12 terms — click to expand)

Reaction	System	Doxycycline	Placebo
GI bleeding	Gastrointestinal disorders	—	—
Flu-like symptoms	Infections and infestations	—	—
Prolonged nosebleed requiring cauterization	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia hospitalization	Infections and infestations	—	—
Allergy-like symptoms	Respiratory, thoracic and mediastinal disorders	—	—
Throat infection	Infections and infestations	—	—
Metastatic lung cancer dx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Sinus infection	Infections and infestations	—	—
Foot infection	Infections and infestations	—	—
Blurred vision	Eye disorders	—	—
Emesis	Gastrointestinal disorders	—	—
Pneumonia	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04167085 adverse events section.

Sponsor's own description

The purpose of this research study is to determine whether Doxycycline can be used to control nosebleeds (epistaxis) for patients with Hereditary Hemorrhagic Telangiectasia (HHT). Patients with HHT will be randomized to one of 2 study arms: Doxycycline or Placebo for a period of 2 months followed by a 1-month washout period before switching treatments for a further 2 months period. Observation and evaluation will continue for a period of one month after treatment is completed.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hereditary hemorrhagic telangiectasia (HHT): a practical guide to management.
   Hammill AM, Wusik K, Kasthuri RS. · · 2021 · cited 29× · PMID 34889398 · DOI 10.1182/hematology.2021000281
2. Review of Pharmacological Strategies with Repurposed Drugs for Hereditary Hemorrhagic Telangiectasia Related Bleeding.
   Albiñana V, Cuesta AM, Rojas-P I, Gallardo-Vara E, et al · · 2020 · cited 20× · PMID 32517280 · DOI 10.3390/jcm9061766
3. Epistaxis Prevention, Treatment, and Future Perspectives for Hereditary Hemorrhagic Telangiectasia.
   Ficany A, Del Alamo M, Bernabeu C, Shovlin CL, et al · · 2025 · PMID 41227119 · DOI 10.3390/jcm14217724