Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

Обзор

TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.

Вмешательства

• Препарат single-inhaler triple therapy (Trimbow)
  Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
• Устройство E-health application: Curavista app & FindAir e-device
  Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
• Препарат multi-inhaler triple therapy (Qvar + Bevespi)
  Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Первичные конечные точки

• Adherence to ICS therapy [Срок оценки: 12 months]

Вторичные конечные точки (9)

• TAI questionnaire score [Срок оценки: 12 months]
• CCQ questionnaire [Срок оценки: 12 months]
• VAS score [Срок оценки: 12 months]
• PIH-NL [Срок оценки: 12 months]
• WPAI [Срок оценки: 12 months]
• EQ-5D-5L [Срок оценки: 12 months]
• HLS-EU-Q16 [Срок оценки: 12 months]
• Number exacerbations [Срок оценки: 12 months]
• SABA use [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Clinical diagnosis of COPD for at least 1 year before the screening visit
• Aged 40 years and older
• An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT).
• Owner of mobile device compatible with e-device app with access to internet (Android or iOS)
• Willing to provide written informed consent
• Current or ex-smoker

Критерии исключения

• Inability to comply with study procedures or with study treatment
• Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed
• Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed
• Use of e-health application for COPD in the past six months
• Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)
• Use of nebulized bronchodilators, for example via pari boy
• Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive
• Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order
• Patients without the capability to complete the questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• Franciscus Gasthuis & Vlietland — Rotterdam

Публикации

• Cuperus LJA, van der Palen J, Aldenkamp A, van Huisstede A, Bischoff EWMA, van Boven JFM, Brijker F, Dik S, van Excel JAJM, Goosens M, van Hal PTW, Kuijvenhoven JC, Kunz LIZ, Vasbinder EC, Kerstjens HAM, In 't Veen JCCM; TRICOLON study group. Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized c PMID 38965541

Идентификаторы

NCT: NCT05495698 · FranciscusGasthuis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗