Anvendelse af steroideinjektioner til at forebygge tilbagefald af trachealstenose ved idiopatisk subglottisk stenose (ASTRO)
Adjuvant STeRoid Resultater i Idiopatisk Subglottal Stenose
This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Alexander Hillel, M.D.
- Telefonnummer: 4432876006
- E-mail: ahillel@jh.edu
Studiesteder
-
-
California
-
San Diego, California, Forenede Stater, 92121
- Ikke rekrutterer endnu
- University of California - San Diego
-
Kontakt:
- Daniel Cates
- E-mail: djcates@health.ucsd.edu
-
Ledende efterforsker:
- Daniel Cates, MD
-
San Francisco, California, Forenede Stater, 94115
- Ikke rekrutterer endnu
- University of California - San Francisco
-
Ledende efterforsker:
- Clark Rosen, MD
-
Kontakt:
- Meera Kohli
- E-mail: meera.kohli@ucsf.edu
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Ikke rekrutterer endnu
- University of Colorado
-
Kontakt:
- Yosr Doghri
- E-mail: yosr.doghri@cuanschutz.edu
-
Ledende efterforsker:
- Matthew Clary, MD
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- University of South Florida
-
Kontakt:
- Jacquie Persaud
- E-mail: jdpersaud@usf.edu
-
Ledende efterforsker:
- Yael Bensoussan, MD
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Hospitals and Clinics
-
Kontakt:
- Emma Thayer
- E-mail: emma-thayer@uiowa.edu
-
Ledende efterforsker:
- Matthew Hoffman, MD, PhD
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
- Johns Hopkins Hospital
-
Ledende efterforsker:
- Alexander Hillel, MD
-
Kontakt:
- Sarah E Collins, M.S.
- Telefonnummer: 434-962-3058
- E-mail: shirsh1@jh.edu
-
Kontakt:
- Sam L Collins, Ph.D.
- Telefonnummer: 4107020420
- E-mail: scollin7@jhmi.edu
-
Underforsker:
- Kevin Motz, MD
-
-
New York
-
Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester Medical Center
-
Kontakt:
- Paul Allen
- E-mail: paul_allen@urmc.rochester.edu
-
Ledende efterforsker:
- G. Todd Schneider, MD, MS
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
-
Ledende efterforsker:
- Alexander Gelbard, MD
-
Kontakt:
- Samantha Salvi Cruz
- E-mail: samantha.salvicruz@vumc.org
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- University of Utah
-
Kontakt:
- Chen Wilson
- E-mail: u0661901@utah.edu
-
Ledende efterforsker:
- Breanne Schiffer, MD, MPH
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- Ikke rekrutterer endnu
- University of Wisconsin - Madison
-
Kontakt:
- Maddie Baranek
- E-mail: baranek@surgery.wisc.edu
-
Ledende efterforsker:
- David Francis, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of iSGS following the NoAAC criteria which involves ruling out known causes for airway stenosis. Participants may be newly diagnosed or carry an existing diagnosis of iSGS;
- Age Range: 18 years to 80 years old at the time of consent;
- Sex distribution: all eligible men and women will be included, and no one will be excluded;
- Have a life expectancy of ≥6 months; and,
- ECOG performance status of 0 or 1.
Exclusion Criteria:
-
History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:
- Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);
- External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;
- Clinical diagnosis of granulomatosis with polyangiitis (GPA);
- Radiation exposure to the neck;
- Complications resulting from the Index Procedure, including needing an endotracheal tube or tracheostomy immediately following surgery or a perforation of the trachea;
-
Current or previous treatment with SILSI;
-
Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;
- Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the Study Drug Dosing phase is not recommended due to potential increased risk of infection.
- Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment.
- Use of inhaled steroids is permitted during the study if the participant was taking at the time of consent, and no new inhaled steroids can be started while enrolled in the study.
-
Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection;
-
Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg);
-
Pulmonary disease including interstitial lung disease or COPD/emphysema;
-
Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of Enrollment;
-
Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days;
-
Participants with active cancer or a history of cancer in the last 5 years prior to enrollment, except for squamous or basal cell carcinoma of the skin;
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Participation in any clinical trial involving an investigational drug or device, within four weeks, or 5 half-lives of the investigational agent (whichever time point is longer) prior to enrollment or during this trial participation;
-
Active autoimmune disease requiring systemic treatment;
-
History of solid organ transplant due to use of immunosuppression;
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Contraindication to any aspect of the index procedure;
-
Inability to tolerate in-office SILSI procedure;
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Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;
-
Contraindication to SMOFlipid including any of the below:
- Severe lipid metabolism disorders characterized by hypertriglyceridemia (greater than 500 mg/dL);
- Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in SMOFlipid;
- History of intolerance to SMOFlipid;
-
Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding;
-
NYHA class II-IV heart failure within the past 6 months prior to Enrollment;
-
History of angioedema;
-
Lack of capacity to consent;
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Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment;
-
Participants who for any reason may not complete the study as judged by the PI;
-
Participants planning to move to another city or state for 6 months after the Index Procedure;
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Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.
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The presence of a medical condition, lab test result, and/or use of a medication and/or any substance, individually or in aggregate, that in the judgement of the site investigator could impair study participation.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intralesional steroidinjektion med Triamcinolon
|
Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation |
|
Placebo komparator: Intralesionel Placebo-injektion
|
Intralesional Placebo injection 3x at one, two, and three months following surgical dilation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ændring i Peak Ekspiratorisk Flow (Liter/min)
Tidsramme: 6 måneder
|
6 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical COPD Questionnaire
Tidsramme: 6 months
|
Score range 0-60, Lower score indicates better health |
6 months
|
|
Voice Handicap Index-10
Tidsramme: 6 Months
|
Score range 0 to 40, Lower score indicates better voice |
6 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alexander Hillel, MD, Johns Hopkins University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00507375
- 1UG3HL173394-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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