- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167085
NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial (NOSTRIL)
Study Overview
Detailed Description
This study will analyze the effect of doxycycline on nosebleeds in hereditary hemorrhagic telangiectasia (HHT), a rare and debilitating medical condition. Patients with HHT have a variety of vascular abnormalities, including changes in their nasal vasculature that result in chronic, severe nosebleeds. These nosebleeds have been shown to significantly reduce the quality of life in HHT and can be severe enough to require emergent blood transfusion. Current therapies to control nosebleeds in HHT, which include both medications and surgical treatments, are inconsistently effective and associated with a variety of problematic side effects and complications.
Doxycycline is a common, FDA-approved antibiotic medication that has been used by physicians for decades. It is a safe medication that can be used on an outpatient basis for extended periods of time with minimal side effects. Recent research has shown that doxycycline is a potent inhibitor of angiogenesis, the process of new blood vessel development. Since the vascular abnormalities in HHT form due to uncontrolled angiogenesis, it follows that doxycycline may have potential in treating HHT. A growing body of research demonstrates the efficacy of doxycycline in treating a variety of vascular conditions, including cancer of the breast, duodenum, liver prostate, and lung. Our trial will be the first to analyze the efficacy of doxycycline in treating HHT epistaxis.
This a randomized, double-blind, crossover study design. Each patient will take both placebo and doxycycline. Since this is a cross-over study, half the participants will start out with taking placebo and half start with doxycyline and then switch halfway through. After a baseline observation period, participants will be given doxycycline at 100 mg twice a day, or an identical-appearing placebo, for a period of three months. Each month they will be seen be a physician, who will take a detailed clinical history and perform a physical examination. Further, each month the patient will have blood testing to assess blood loss, and fill out scientifically validated surveys to assess quality of life and the severity of bleeding. Following this three month treatment period, participants will be observed for one additional month, with one additional blood test and clinical assessment performed after this month.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- 100 UCLA Medical Plaza
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Doxycycline, then Placebo
Doxycycline for a period of 2 months followed by a 1-month washout period, and then placebo for a further 2 months period followed by a 1-month washout period.
|
Doxycycline, 100 mg twice a day for 2 months
Matching placebo, twice a day for 2 months
|
Experimental: Placebo, then Doxycycline
Placebo for a period of 2 months followed by a 1-month washout period, and then Doxycycline for a further 2 months period followed by a 1-month washout period.
|
Doxycycline, 100 mg twice a day for 2 months
Matching placebo, twice a day for 2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Epistaxis
Time Frame: Baseline, post-washout - approximately 6 months
|
Change in number of bleeding episodes per week by participant self-report via nosebleed diary
|
Baseline, post-washout - approximately 6 months
|
Duration of Epistaxis
Time Frame: Baseline, post-washout - approximately 6 months
|
Change in duration of bleeding per week by patient self-report via nosebleed diary
|
Baseline, post-washout - approximately 6 months
|
Change in Severity of Epistaxis
Time Frame: 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.
|
Baseline, post-washout - approximately 6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: 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.
|
Baseline, post-washout - approximately 6 months
|
Change in Ferritin Level
Time Frame: Baseline, post-washout - approximately 6 months
|
Baseline, post-washout - approximately 6 months
|
|
Change in Hemoglobin Level
Time Frame: Baseline, post-washout (approximately 6 months)
|
Baseline, post-washout (approximately 6 months)
|
|
Change in Monthly Units of Packed Red Blood Cells (PRBCs) Transfused
Time Frame: Baseline, post-washout (approximately 6 months)
|
Baseline, post-washout (approximately 6 months)
|
|
Incidence of Treatment Failure
Time Frame: Baseline, post-washout (approximately 6 months)
|
Treatment failure, defined as need for nasal surgery or other epistaxis treatments
|
Baseline, post-washout (approximately 6 months)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-001827
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epistaxis
-
NasaClipEmergency Medical Innovations, LLCRecruiting
-
Bezmialem Vakif UniversityCompleted
-
Izmir Ataturk Training and Research HospitalCompletedTranexamic Acid | Anterior EpistaxisTurkey
-
University of ZurichCompletedNosebleed (Epistaxis) - Posterior or AnteriorSwitzerland
-
University Hospital, Strasbourg, FranceRecruitingEpistaxis, Anterior Ethmoid ArteryFrance
-
Buddhist Tzu Chi General HospitalUnknownInjury Due to Endoscopic Examination | Transnasal Endoscopy Induced Epistaxis | Transnasal Endoscopy Induced Nasal PainTaiwan
-
University of AlbertaCompleted
-
Combined Military Hospital, PakistanCompleted
-
University of British ColumbiaCompleted
Clinical Trials on Doxycycline
-
Thomas GardnerJuvenile Diabetes Research FoundationCompleted
-
University of PittsburghTu Du HospitalCompleted
-
Par Pharmaceutical, Inc.AnapharmCompletedTo Determine Bioequivalence Under Fed ConditionsCanada
-
Warner ChilcottCompletedAcne VulgarisUnited States
-
PfizerCompleted
-
Warner ChilcottCompleted
-
Samsung Medical CenterCompleted
-
Chinese University of Hong KongNot yet recruitingChlamydia | Gonorrhea | Sexually Transmitted Diseases, Bacterial | SyphilisHong Kong
-
University Medical Centre LjubljanaUniversity of Ljubljana School of Medicine, SloveniaCompleted
-
Aljazeera HospitalUnknown