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NCT06678191Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 22 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
800 (estimated)
First submitted
9 Oct 2024
Start date
24 Oct 2024
Primary completion date
31 Oct 2026
Lead sponsor
Chiesi Hungary Ltd.
Diseases
Asthma, COPD
NCT number
NCT06678191

What you commit to

  • Study type: Observational
  • Planned participants: 800
  • From 24 Oct 2024 to the primary completion date, 31 Oct 2026
  • 45 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • Actual or previous use of biologics for asthma treatment in the past 12 months

Other illness

  • 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.
  • Any malignant disease in the last 5 years
  • Tuberculosis (active or anamnestic)

Other

  • All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC

Who the study is looking for

  • 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
    • LABA - high dose ICS OR
    • 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
    • At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
    • Uncontrolled asthma (ACT≤15)
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Békés Megyei Központi Kórház, 2. Tüdőgyógyászat szakrendelés - 1. rendelés
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BékéscsabaHungaryRecruiting
Semmelweis Egyetem, Általános Orvostudományi Kar, Pulmonológiai Klinika
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BudapestHungaryRecruiting
Szent Kristóf Szakrendelő XI. Kerületi Tüdőgondozó
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BudapestHungaryRecruiting
Országos Korányi Pulmonológiai Intézet (OKPI)
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BudapestHungaryRecruiting
Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
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BudapestHungaryRecruiting
XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Tüdőgyógyászat
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BudapestHungaryRecruiting
Szent Kristóf Szakrendelő XXII. Kerületi Tüdőgondozó
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BudapestHungaryRecruiting
Csornai Margit Kórház Tüdőbeteggondozó Intézet
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CsornaHungaryRecruiting
Debreceni Egyetem Klinikai Központ Allergológiai Szakrendelés
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DebrecenHungaryRecruiting
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Pulmonológiai Részleg
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DebrecenHungaryRecruiting
DE Klinikai Központ, Tüdőgyógyászati Klinika
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DebrecenHungaryRecruiting
SZTE SZAKK Deszki Multidiszciplináris Centrum
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DeszkHungaryRecruiting
Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
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DunakesziHungaryRecruiting
Vaszary Kolos Kórház Tüdőgondozó Esztergom
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EsztergomHungaryRecruiting
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
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FehérgyarmatHungaryRecruiting
Bugát Pál Kórház Tüdőbeteg Gondozó Intézet
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GyöngyösHungaryRecruiting
Petz Aladar Megyei Oktato Korhaz
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GyőrHungaryRecruiting
Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés
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GyulaHungaryRecruiting
Hajduböszörmény ESZ-V Nonprofit Kft Tüdőgyógyászat
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HajdúböszörményHungaryRecruiting
Tüdőgondozó / Szent Erzsébet Kórház
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JászberényHungaryRecruiting
Szent Kereszt Kórház Kalocsa,Tüdőgyógyászati Szakrendelés
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KalocsaHungaryRecruiting
Somogy Megyei Kaposi Mór Oktató Kórház
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KaposvárHungaryRecruiting
Keszthelyi Kórház Tüdőgondozó
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KeszthelyHungaryRecruiting
Kisteleki Egészségügyi Központi Nonprofit Kft.
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KistelekHungaryRecruiting
Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.
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KisvárdaHungaryRecruiting
Selye János Kórház Tüdőgyógyászati Szakellátás
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KomáromHungaryRecruiting
Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat
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KunszentmártonHungaryRecruiting
Szaplonczay Manó Marcali Kórház Tüdőgyógyászati Szakrendelés
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MarcaliHungaryRecruiting
Mátrai Gyógyintézet Légzőszervi szakrendelés
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MátraházaHungaryRecruiting
Karolina Kórház-Rendelőintézet Mosonmagyaróvár
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MosonmagyaróvárHungaryRecruiting
Kanizsai Dorottya Korhaz
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NagykanizsaHungaryRecruiting
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
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NyírbátorHungaryRecruiting
Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház Megyei-Városi Tüdőgondozó
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NyíregyházaHungaryRecruiting
Orosházi Kórház Tüdőgondozó
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OrosházaHungaryRecruiting
Margit Kórház Pásztó Tüdőgyógyászati Szakrendelés
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PásztóHungaryRecruiting
Egyesített Egészségügyi Intézmények Tüdőgondozó
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PécsHungaryRecruiting
Sarkadi Kistérségi Járóbeteg Szakellátó Központ
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SarkadHungaryRecruiting
Siófoki Kórház-Rendelőintézet Tüdőgondozó
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SiófokHungaryRecruiting
Csongrád Megyei Mellkasi Betegségek Szakkórháza, Tüdőgondozó Intézet
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SzegedHungaryRecruiting
Alba Szűrőközpont
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SzékesfehérvárHungaryRecruiting
Fejér Megyei Szent György Egyetemi Oktató Kórház, Tüdőbeteg Gondozó, Városkörnyék I. Szakrendelés Székesfehérvár
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SzékesfehérvárHungaryRecruiting
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés
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SzolnokHungaryRecruiting
Markusovszky Egyetemi Oktatokorhaz
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SzombathelyHungaryRecruiting
Református Pulmonológiai Centrum, Törökbálint
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TörökbálintHungaryRecruiting
Zala Megyei Szent Rafael Korhaz
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ZalaegerszegHungaryRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.