Phase 4
Completed N=26
NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
Source: ClinicalTrials.gov NCT04167085 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Frequency of Epistaxis — -1.68; 1.14 Nosebleeds per week — p=0.16
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Epistaxis |
-1.68; 1.14 | 0.16 |
| PRIMARY Duration of Epistaxis |
-41.17; 24.36 | 0.05 |
| PRIMARY Change in Severity of Epistaxis |
-.095; -0.32 | 0.19 |
| SECONDARY Change in Quality of Life |
2.21; -0.83; -0.63; -0.63 | 0.24 |
| SECONDARY Change in Ferritin Level |
14.9; -47.4 | 0.50 |
| SECONDARY Change in Hemoglobin Level |
0.26; -0.12 | 0.30 |
| SECONDARY Change in Monthly Units of Packed Red Blood Cells (PRBCs) Transfused |
0; 0 | 1.00 |
| SECONDARY Incidence of Treatment Failure |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of definite HHT by the Curacao criteria or genetic diagnosis of HHT
- Epistaxis severity during observation month at least moderate by Epistaxis Severity Score (ESS) evaluation
- For female participants, a negative pregnancy test at Day -1 and agree to use birth control during treatment and for 28 days following cessation of Doxycycline
Exclusion Criteria
- Use of medication(s) contraindicated with doxycycline use within 14 days prior to the study (including barbiturates, tegretol, dilantin, warfarin, isotretinoin)
Data sourced from ClinicalTrials.gov (NCT04167085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.