Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting (STRENGTH)

November 20, 2024 updated by: Chiesi Hungary Ltd.

Effectiveness of BDP/FF/G 172/5/9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment

The mainstay of asthma treatment are ICSs, mostly combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorisation of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life. Also, there is scarcity of data regarding the phenotypes of asthmatics who benefit the most from the use of fixed triple combinations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design Multicentre, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS containing treatment in asthmatics.

Dosage regimen and administration Name of the product: Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (henceforth abbreviated as Trimbow 172/5/9 μg pMDI). Each delivered dose (the dose leaving the mouthpiece) contains 172 μg of beclometasone dipropionate, 5 μg of formoterol fumarate dihydrate and 9 μg of glycopyrronium (as 11 μg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium (as 12.5 μg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily.

  1. Aim of the study (research objective)

    Primary objective:

    The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT).

  2. Test sample and method, recruitment principle No patient recruitment will be performed. Eligible patients will be enrolled during the participating physicians' regular asthma patient management and patients' written informed consent. Patient inclusion will take place among patients having severe asthma and attending pulmonology outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patients' visit. The planned number of patients is 800.

  3. Structure of the study In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all of its details, and the patient has read and signed the patient information leaflet and patient consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values (if spirometry data is available), laboratory results (if a laboratory test is performed during the visit or was performed recently), results of other medical examinations (e.g., chest X-ray) if performed regardless of the study, maintenance and reliever inhaled & non-inhaled therapies (former and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L) questionnaire, and adherence to therapy based on Test of Adherence to Inhalers® (TAI-12) questionnaire are recorded. Patients will then attend two additional visits 30 days and 6 months after enrolment as per routine clinical practice (Visits 2 and 3). During these visits, data will also be recorded, once again, according to routine clinical practice. Assessing the usage of rescue medications and patient adherence are also planned with the use of electronic health record system (EESZT)-verified prescription dispensations (optional for investigators). Visit 4 will be a long-term follow-up to assess the exploratory endpoint of exacerbations rates.

    If the patient's maintenance therapy changes during the study as decided by the treating pulmonologist, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The fact of the therapy modification and its exact date must be recorded on the "current medication" form in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately on the eCRF platform in accordance with section 9 of this protocol ('Collection, recording and reporting of medication safety data').

    This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma. The data to be recorded will be detailed in the study data sheet that forms part of the protocol. The data is recorded in the eCRF (MrAgent - Medisol Development Ltd., see also at 10.1.) system, with consideration to the current professional and legal regulations.

  4. Start and duration of the study The first patient enrolment will take place after receiving approval from the National Public Health Center (NPHC), based on a beneficial assessment of the Medical Research Council of Hungary. The study is planned to start on September 16, 2024. Accordingly, first patient first visit (FPFV) is also planned to take place in September, 2024. The launch of the participating centres is planned in two waves, in the autumn of 2024 and in the spring of 2025. Each centre will have 12 months to enrol patients. After the last visit of the last patient (LPLV), centres will have one month to collect all missing data / correct any data flagged as queries during monitoring. Thus, the LPLV will take place on Oct 31, 2026 (primary endpoint) and 30 April, 2027 (exploratory endpoint), respectively. The study is planned to be concluded on August 31, 2027.

  5. Data to be recorded during the visits A total of 4 visits will be performed for the assessment of the primary and secondary endpoints during the study. The table below summarises the data collection to be carried out during the visits separately. The patient may be enrolled in the study and their data may only be recorded, if these data would also have been recorded in accordance with standard medical practice.

    • Visit 1: Time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected.
    • Visit 2: 1 month after enrolment (± 2-3 workdays)
    • Visit 3: 6 months after enrolment (± 5-7 workdays)
    • Visit 4: 12 months after enrolment (± 10-15 days)

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
        • Contact:
          • Brigitta Dombai, Dr.
        • Sub-Investigator:
          • Brigitta Dombai, Dr.
        • Sub-Investigator:
          • Andrea BÍró, Dr.
      • Budapest, Hungary
        • Recruiting
        • Országos Korányi Pulmonológiai Intézet (OKPI)
        • Contact:
          • Zsuzsanna Csoma, Dr.
        • Principal Investigator:
          • Zsuzsanna CSoma, Dr.
      • Budapest, Hungary
        • Recruiting
        • Semmelweis Egyetem, Általános Orvostudományi Kar, Pulmonológiai Klinika
        • Contact:
          • Lilla Tamási, Prof.
        • Sub-Investigator:
          • Noémi Eszes, Dr.
        • Sub-Investigator:
          • Edit Hídvégi, Dr.
        • Sub-Investigator:
          • Tamás Erdélyi, Dr.
        • Principal Investigator:
          • Lilla Tamási, Prof.
      • Budapest, Hungary
        • Recruiting
        • Szent Kristóf Szakrendelő XI. Kerületi Tüdőgondozó
        • Contact:
          • Ildikó Nádudvary, Dr.
        • Sub-Investigator:
          • Ildikó Nádudvary, Dr.
        • Sub-Investigator:
          • Erzsébet Juhász, Dr.
        • Sub-Investigator:
          • Katalin Major, Dr.
      • Budapest, Hungary
        • Recruiting
        • Szent Kristóf Szakrendelő XXII. Kerületi Tüdőgondozó
        • Contact:
          • Lívia Medek, Dr.
        • Principal Investigator:
          • Lívia Medek, Dr.
      • Budapest, Hungary
        • Recruiting
        • XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Tüdőgyógyászat
        • Contact:
          • Éva Tót, Dr.
        • Principal Investigator:
          • Éva Tót, Dr.
        • Sub-Investigator:
          • Márta Molnár, Dr.
      • Békéscsaba, Hungary
        • Recruiting
        • Békés Megyei Központi Kórház, 2. Tüdőgyógyászat szakrendelés - 1. rendelés
        • Contact:
          • Árpád Vincze, Dr.
        • Sub-Investigator:
          • Árpád Vincze, Dr
        • Sub-Investigator:
          • Péter Martyin, Dr
        • Sub-Investigator:
          • Károly Tébi, Dr
      • Csorna, Hungary
        • Recruiting
        • Csornai Margit Kórház Tüdőbeteggondozó Intézet
        • Contact:
          • Zoltán Bártfai, Dr
        • Principal Investigator:
          • Zoltán Bártfai, Dr.
      • Debrecen, Hungary
        • Recruiting
        • DE Klinikai Központ, Tüdőgyógyászati Klinika
        • Contact:
          • László Brúgos, Dr
        • Principal Investigator:
          • László Brúgos, Dr
        • Sub-Investigator:
          • Angéla Mikáczó, Dr
      • Debrecen, Hungary
        • Recruiting
        • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Pulmonológiai Részleg
        • Contact:
          • Réka Keszthelyi, Dr.
        • Principal Investigator:
          • Réka Keszthelyi, Dr.
        • Sub-Investigator:
          • Éva Kalmár, Dr.
      • Debrecen, Hungary
        • Recruiting
        • Debreceni Egyetem Klinikai Központ Allergológiai Szakrendelés
        • Contact:
          • Erzsébet Takács, Dr.
        • Principal Investigator:
          • Erzsébet Takács, Dr
      • Deszk, Hungary
        • Recruiting
        • SZTE SZAKK Deszki Multidiszciplináris Centrum
        • Contact:
          • Klára Szalontay, Dr.
        • Principal Investigator:
          • Klára Szalontay, Dr.
      • Dunakeszi, Hungary
        • Recruiting
        • Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
        • Contact:
          • Katalin Kontz, Dr.
        • Principal Investigator:
          • Katalin Kontz, Dr.
      • Esztergom, Hungary
        • Recruiting
        • Vaszary Kolos Kórház Tüdőgondozó Esztergom
        • Contact:
          • Gabriella Horváth, Dr.
        • Principal Investigator:
          • Gabriella Horváth, Dr.
      • Fehérgyarmat, Hungary
        • Recruiting
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
        • Contact:
          • Sándor Tóth, Dr.
        • Principal Investigator:
          • Sándor Tóth, Dr.
      • Gyula, Hungary
        • Recruiting
        • Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés
        • Contact:
          • Árpád Vincze, Dr
        • Principal Investigator:
          • Árpád Vincze, Dr.
      • Gyöngyös, Hungary
        • Recruiting
        • Bugát Pál Kórház Tüdőbeteg Gondozó Intézet
        • Contact:
          • Csilla Szabó, Dr
        • Sub-Investigator:
          • Csilla Szabó, Dr.
        • Sub-Investigator:
          • Valéria Sípos, Dr.
      • Győr, Hungary
        • Recruiting
        • Petz Aladar Megyei Oktato Korhaz
        • Contact:
          • Márta Czompó, Dr.
        • Principal Investigator:
          • Márta Czompó, Dr.
      • Hajdúböszörmény, Hungary
        • Recruiting
        • Hajduböszörmény ESZ-V Nonprofit Kft Tüdőgyógyászat
        • Contact:
          • Gabriella Kiss, Dr.
        • Principal Investigator:
          • Gabriella Kiss, Dr.
      • Jászberény, Hungary
        • Recruiting
        • Tüdőgondozó / Szent Erzsébet Kórház
        • Contact:
          • Ida Nagy, dr.
        • Principal Investigator:
          • Ida Nagy, Dr.
      • Kalocsa, Hungary
        • Recruiting
        • Szent Kereszt Kórház Kalocsa,Tüdőgyógyászati Szakrendelés
        • Contact:
          • Szabolcs Körmendy, Dr.
        • Principal Investigator:
          • Szabolcs Körmendy, Dr.
      • Kaposvár, Hungary
        • Recruiting
        • Somogy Megyei Kaposi Mor Oktato Korhaz
        • Contact:
          • Éva Kuczkó, Dr.
        • Principal Investigator:
          • Éva Kuczkó, Dr.
      • Keszthely, Hungary
        • Recruiting
        • Keszthelyi Kórház Tüdőgondozó
        • Contact:
          • Sándor Tehenes, Dr.
        • Principal Investigator:
          • Sándor Tehenes, Dr.
      • Kistelek, Hungary
        • Recruiting
        • Kisteleki Egészségügyi Központi Nonprofit Kft.
        • Contact:
          • Ágnes Selypes, Dr.
        • Principal Investigator:
          • Ágnes Selypes, Dr.
      • Kisvárda, Hungary
        • Recruiting
        • Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.
        • Contact:
          • Miklós Kukuly, Dr.
        • Principal Investigator:
          • Miklós Kukuly, Dr.
      • Komárom, Hungary
        • Recruiting
        • Selye János Kórház Tüdőgyógyászati Szakellátás
        • Contact:
          • Judit Schlezák, Dr.
        • Principal Investigator:
          • Judit Schlezák, Dr.
        • Sub-Investigator:
          • Éva Szenes, Dr.
      • Kunszentmárton, Hungary
        • Recruiting
        • Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat
        • Contact:
          • Tibor Süveges, Dr.
        • Principal Investigator:
          • Tibor Süveges, Dr.
      • Marcali, Hungary
        • Recruiting
        • Szaplonczay Manó Marcali Kórház Tüdőgyógyászati Szakrendelés
        • Contact:
          • Jakoob Maha, Dr.
        • Principal Investigator:
          • Jakoob Maha, Dr.
      • Mosonmagyaróvár, Hungary
        • Recruiting
        • Karolina Kórház-Rendelőintézet Mosonmagyaróvár
        • Contact:
          • Erika Unger, Dr.
        • Principal Investigator:
          • Erika Unger, Dr.
      • Mátraháza, Hungary
        • Recruiting
        • Mátrai Gyógyintézet Légzőszervi szakrendelés
        • Contact:
          • Magdolna Horváth, Dr.
        • Principal Investigator:
          • Magdolna Horváth, Dr.
      • Nagykanizsa, Hungary
        • Recruiting
        • Kanizsai Dorottya Korhaz
        • Contact:
          • Magdolna Tankó, Dr.
        • Principal Investigator:
          • Magdolna Tankó, Dr.
      • Nyírbátor, Hungary
        • Recruiting
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
        • Contact:
          • Krisztina Alb, Dr.
        • Principal Investigator:
          • Krisztina Alb, Dr.
      • Nyíregyháza, Hungary
        • Recruiting
        • Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház Megyei-Városi Tüdőgondozó
        • Contact:
          • Ildikó Kerényi, Dr.
        • Principal Investigator:
          • Ildikó Kerényi, Dr.
        • Sub-Investigator:
          • Rozália Fráter, Dr.
        • Sub-Investigator:
          • Katalin Kaposi, Dr.
      • Orosháza, Hungary
        • Recruiting
        • Orosházi Kórház Tüdőgondozó
        • Contact:
          • Erika Vecsey, Dr.
        • Principal Investigator:
          • Erika Vecsesy, Dr.
      • Pásztó, Hungary
        • Recruiting
        • Margit Kórház Pásztó Tüdőgyógyászati Szakrendelés
        • Contact:
          • Margit Füleki, Dr.
        • Principal Investigator:
          • Margit Füleki, Dr.
      • Pécs, Hungary
        • Recruiting
        • Egyesített Egészségügyi Intézmények Tüdőgondozó
        • Contact:
          • Ágnes Varga, Dr
        • Principal Investigator:
          • Ágnes Varga, Dr.
      • Sarkad, Hungary
        • Recruiting
        • Sarkadi Kistérségi Járóbeteg Szakellátó Központ
        • Contact:
          • István Lopusnyik, Dr.
        • Principal Investigator:
          • István Lopusnyik, Dr.
      • Siófok, Hungary
        • Recruiting
        • Siófoki Kórház-Rendelőintézet Tüdőgondozó
        • Contact:
          • Anna Bartha, Dr.
        • Principal Investigator:
          • Anna Bartha, Dr.
      • Szeged, Hungary
        • Recruiting
        • Csongrád Megyei Mellkasi Betegségek Szakkórháza, Tüdőgondozó Intézet
        • Contact:
          • László Makk, Dr
        • Sub-Investigator:
          • László Makk, Dr.
        • Sub-Investigator:
          • Edit Füzesi, Dr.
        • Sub-Investigator:
          • András Imréné Mihály, Dr.
      • Szolnok, Hungary
        • Recruiting
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés
        • Contact:
          • Tibor Juhász, Dr.
        • Sub-Investigator:
          • Tibor Juhász, Dr.
        • Sub-Investigator:
          • Ildikó Szeredai, Dr.
      • Szombathely, Hungary
        • Recruiting
        • Markusovszky Egyetemi Oktatókórház
        • Contact:
          • Krisztina Hajdú, Dr.
        • Principal Investigator:
          • Krisztina Hajdú, Dr.
      • Székesfehérvár, Hungary
        • Recruiting
        • Alba Szűrőközpont
        • Contact:
          • Zsolt Vidák, Dr.
        • Principal Investigator:
          • Zsolt Vidák, Dr
      • Székesfehérvár, Hungary
        • Recruiting
        • Fejér Megyei Szent György Egyetemi Oktató Kórház, Tüdőbeteg Gondozó, Városkörnyék I. Szakrendelés Székesfehérvár
        • Contact:
          • Nóra Ferenczy, Dr.
        • Principal Investigator:
          • Nóra Ferenczy, Dr.
      • Törökbálint, Hungary
        • Recruiting
        • Református Pulmonológiai Centrum, Törökbálint
        • Contact:
          • Csilla Farkas, Dr.
        • Sub-Investigator:
          • Csilla Farkas, Dr.
        • Sub-Investigator:
          • Eszter Őri, Dr.
      • Zalaegerszeg, Hungary
        • Recruiting
        • Zala Megyei Szent Rafael Korhaz
        • Contact:
          • Márta Beke, Dr.
        • Sub-Investigator:
          • Márta Beke, Dr.
        • Sub-Investigator:
          • Mária Steierlein, Dr.
        • Sub-Investigator:
          • Zsuzsanna Vecsey, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Asthma patients treated at GINA step 5, uncontrolled with ICS-LABA, containing high dose ICS.

Description

INCLUSION CRITERIA:

  • Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
  • Patients ≥ 18 years of age in ambulatory care

  • Uncontrolled asthma according to the physician's clinical assessment despite the use of

    1. LABA - high dose ICS OR
    2. LABA - high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.

  • Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC and the financing protocol for asthma

    1. At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
    2. Uncontrolled asthma (ACT≤15)
    3. FEV1<80% at baseline
  • Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 1 week prior to OR on the day of study inclusion
  • Patient provided written, informed consent to study participation

EXCLUSION CRITERIA:

  • Participation in any clinical trial within 30 days prior to enrolment
  • Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment
  • Another respiratory condition, apart from asthma or COPD, that may interfere with the effectiveness of the treatment studied AND/OR another important clinical situation that may interfere with patient's compliance with the treatment.
  • Continuous use of oral (>5 mg prednisolone/day OR >4 mg methylprednisolone/day) OR intravenous corticosteroids CHMED_2024/01 Prof. Dr. Lilla Tamási 8(17)
  • Use of continuous oxygen therapy
  • Any malignant disease in the last 5 years
  • Tuberculosis (active or anamnestic)
  • Actual or previous use of biologics for asthma treatment in the past 12 months
  • All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)
Asthmatic patients who had been switched to BDP/FF/G 172/5/9 μg before study enrollment, due to uncontrolled asthma.
Drug: BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg
In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control Test
Time Frame: 6 months
Change (improvement) of asthma control test (ACT) score, during the 6 months of treatment (Visit 3), compared to the score at baseline.
6 months
Asthma control Test 2
Time Frame: 6 months
• The percentage of patients achieving an improvement in asthma control test (ACT) score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL
Time Frame: 6 months
Change in Health-related QoL was assessed by measuring the 5-level EuroQoL 5-dimension component (EQ-5D-5L) index score at Visit 3 (6 months), compared to the baseline visit 1 (Week 0), regarding the assessment of the impact of Asthma on the patient's quality of life.
6 months
Adherence
Time Frame: 6 months
Change in Test of Adherence to Inhalers® (TAI-12) score at Visit 3 (6 months) compared to baseline visit (Visit 1, week 0) regarding adherence to treatment with use of the Trimbow 172/5/9 μg pMDI.
6 months
Lung function
Time Frame: 6 months
Change in spirometric parameters: FEV1, FVC, FEV1/FVC, at Visit 3 (6 months), compared to the baseline Visit 1 (Week 0), with use of the Trimbow 172/5/9 μg pMDI.
6 months
Asthma control test change
Time Frame: 6 months
The percentage of patients achieving an improvement according to asthma control levels (uncontrolled= ACT ≤15; partially controlled= 15<ACT<20; controlled 20≤ACT)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbations
Time Frame: 12 months
Changes in moderate and severe exacerbation rates at Visit 4 (12 months), compared to the baseline Visit 1 (Week 0), with use of the Trimbow 172/5/9 μg pMDI
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Hungary Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMED_2024/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IDP is sole property of the sponsor and will only be eligible upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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