- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07816718
Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Randomized Control Trial (SARRE-COMS)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.
This pilot randomized controlled trial will evaluate whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The study will also assess whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.
Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to these results.
Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, sputum cell analysis, computed tomography (CT) imaging, and magnetic resonance imaging (MRI). The study will compare asthma remission, relapse, airway inflammation, and structural airway abnormalities between groups.
The findings from this study will provide preliminary evidence regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and may inform future larger clinical trials and personalized treatment approaches.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hana Serajeddini, MD, FRCPC
- Numer telefonu: 66288 (519) 646-6100
- E-mail: hana.serajeddini@lhsc.on.ca
Lokalizacje studiów
-
-
Ontario
-
London, Ontario, Kanada, N6A 4V2
- St. Joseph's Health Care London
-
Kontakt:
- Tommy Li
- Numer telefonu: (519) 646-6100
- E-mail: zli3569@uwo.ca
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
• Patient understands study procedures and is will to participate in the study as indicated by the patient's signature.
- Provision of written, informed consent prior to any study specific procedures.
- Males and females ≥ 18 years of age.
- Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy).
- Eligible for initiation of biologic therapy for treatment of asthma.
- Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
- True sexual abstinence
- A vasectomized sexual partner
- Implanon®
- Female sterilization by tubal occlusion
- Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
- Depo-Provera™ injections
- Oral contraceptive
- Evra Patch™
- Nuvaring™
- Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and X weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1 and Visit 5.
- Male participants who are sexually active must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until X weeks after last dose.
Exclusion Criteria:
• Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis).
- Patients with incomplete medical records.
- Patients who have received biologic treatment for asthma within the last 6 months.
- Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
- Patients with contraindications to PFT, sputum induction, CT or MRI imaging.
- Patients who are pregnant or breastfeeding.
- Patients who are unable or unwilling to comply with study procedures.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Comprehensive Management (Intervention)
Participants will receive asthma management according to routine clinical practice plus a comprehensive biomarker-guided management strategy.
Specialized biomarker results will be made available to the treating clinician and may be used to guide treatment decisions.
|
Intervention Description Participants will receive asthma management according to routine clinical practice in addition to a comprehensive biomarker-guided management strategy. Specialized biomarker assessments, including sputum cell analysis and imaging biomarkers, will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management. Treatment decisions may be informed by these specialized biomarker results throughout the 12-month study period. |
|
Aktywny komparator: Standard of Care
Participants will receive asthma management according to routine clinical practice.
Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions.
|
Participants will receive asthma management according to routine clinical practice.
Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse
Ramy czasowe: Baseline to Month 12
|
To evaluate the association between baseline specialized clinical, physiologic, airway inflammatory, and imaging biomarkers and asthma outcomes, including sustained remission and relapse, over the 12-month follow-up period.
The predictive performance of specialized biomarkers will be compared with that of conventionally available biomarkers.
|
Baseline to Month 12
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Choroby układu odpornościowego
- Choroby Układu Oddechowego
- Choroby płuc
- Choroby oskrzeli
- Choroby płuc, obturacyjne
- Nadwrażliwość oddechowa
- Nadwrażliwość, natychmiastowa
- Nadwrażliwość
- Stany patologiczne, oznaki i objawy
- Astma
- Choroba
- Administracja usług zdrowotnych
- Jakość opieki zdrowotnej, dostęp i ocena
- Jakość opieki zdrowotnej
- Wskaźniki jakości, opieka zdrowotna
- Standard opieki
Inne numery identyfikacyjne badania
- SJHC 005
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .