Bruk av steroideinjektjoner for å forhindre tilbakefall av tracheal stenose ved idiopatisk subglottisk stenose (ASTRO)
Adjuvant STeRoid-resultater ved idiopatisk subglottisk 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Alexander Hillel, M.D.
- Telefonnummer: 4432876006
- E-post: ahillel@jh.edu
Studiesteder
-
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California
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San Diego, California, Forente stater, 92121
- Har ikke rekruttert ennå
- University of California - San Diego
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Ta kontakt med:
- Daniel Cates
- E-post: djcates@health.ucsd.edu
-
Hovedetterforsker:
- Daniel Cates, MD
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San Francisco, California, Forente stater, 94115
- Har ikke rekruttert ennå
- University of California - San Francisco
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Hovedetterforsker:
- Clark Rosen, MD
-
Ta kontakt med:
- Meera Kohli
- E-post: meera.kohli@ucsf.edu
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Har ikke rekruttert ennå
- University of Colorado
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Ta kontakt med:
- Yosr Doghri
- E-post: yosr.doghri@cuanschutz.edu
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Hovedetterforsker:
- Matthew Clary, MD
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Florida
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- University of South Florida
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Ta kontakt med:
- Jacquie Persaud
- E-post: jdpersaud@usf.edu
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Hovedetterforsker:
- Yael Bensoussan, MD
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Hospitals and Clinics
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Ta kontakt med:
- Emma Thayer
- E-post: emma-thayer@uiowa.edu
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Hovedetterforsker:
- Matthew Hoffman, MD, PhD
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Maryland
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Baltimore, Maryland, Forente stater, 21231
- Rekruttering
- Johns Hopkins Hospital
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Hovedetterforsker:
- Alexander Hillel, MD
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Ta kontakt med:
- Sarah E Collins, M.S.
- Telefonnummer: 434-962-3058
- E-post: shirsh1@jh.edu
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Ta kontakt med:
- Sam L Collins, Ph.D.
- Telefonnummer: 4107020420
- E-post: scollin7@jhmi.edu
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Underetterforsker:
- Kevin Motz, MD
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New York
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Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester Medical Center
-
Ta kontakt med:
- Paul Allen
- E-post: paul_allen@urmc.rochester.edu
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Hovedetterforsker:
- G. Todd Schneider, MD, MS
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Tennessee
-
Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
-
Hovedetterforsker:
- Alexander Gelbard, MD
-
Ta kontakt med:
- Samantha Salvi Cruz
- E-post: samantha.salvicruz@vumc.org
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- University of Utah
-
Ta kontakt med:
- Chen Wilson
- E-post: u0661901@utah.edu
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Hovedetterforsker:
- Breanne Schiffer, MD, MPH
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- Har ikke rekruttert ennå
- University of Wisconsin - Madison
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Ta kontakt med:
- Maddie Baranek
- E-post: baranek@surgery.wisc.edu
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Hovedetterforsker:
- David Francis, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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;
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Current or previous treatment with SILSI;
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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.
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Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection;
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Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg);
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Pulmonary disease including interstitial lung disease or COPD/emphysema;
-
Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of Enrollment;
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Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days;
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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;
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Active autoimmune disease requiring systemic treatment;
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History of solid organ transplant due to use of immunosuppression;
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Contraindication to any aspect of the index procedure;
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Inability to tolerate in-office SILSI procedure;
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Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;
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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;
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Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding;
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NYHA class II-IV heart failure within the past 6 months prior to Enrollment;
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History of angioedema;
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Lack of capacity to consent;
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Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment;
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Participants who for any reason may not complete the study as judged by the PI;
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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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intralesional steroidinjection med Triamcinolon
|
Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation |
|
Placebo komparator: Intralesionell Placebo-injeksjon
|
Intralesional Placebo injection 3x at one, two, and three months following surgical dilation |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Endring i topp ekspiratorisk strømningsrate (liter/min)
Tidsramme: 6 måneder
|
6 måneder
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alexander Hillel, MD, Johns Hopkins University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00507375
- 1UG3HL173394-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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