Implementation of a Joint Pulmonologist and ENT Consultation in the Care Pathway of Patients Suffering From Asthma and Chronic Rhinosinusitis With Nasal Polyposis: Effectiveness Compared With Consultations by Specialty (CON-PO Study).

Обзор

Asthma affects the lower respiratory tract (bronchi), whereas chronic rhinosinusitis with nasal polyposis (CRSwNP) involves the upper airways. Despite this anatomical distinction, the upper and lower airways form a continuous respiratory tract and share common pathophysiological mechanisms. Consequently, asthma and CRSwNP frequently coexist, and several therapeutic strategies are effective for both conditions. Given these overlaps, we hypothesize that a multidisciplinary consultation involving both a pulmonologist and an ENT specialist could be more effective than separate consultations for patient care. We also believe that this innovative organization that would benefit the healthcare system. To test this hypothesis, we are conducting a study whose primary objective is to assess whether joint consultations lead to a reduction in oral corticosteroid need over the year following the initial consultation, by enabling more personalized treatment strategies. Secondary outcomes will include the frequency of asthma exacerbations, frequency of ENT-related events, respiratory symptoms, quality of life, and healthcare ressources utilization. We will compare outcomes between two patient groups: one receiving joint consultation from both specialists, and the other managed through standard, separate consultations as per current clinical practice.

Вмешательства

• Другое Joint consultation
  Joint consultation with pneumologist and ENT at baseline.
• Процедура Mucus sampling
  Mucus sampling at baseline and one year follow-up
• Процедура Nasal brushing
  Nasal brushing at baseline and one year follow-up

Первичные конечные точки

• Effectiveness of joint ENT and pulmonologist consultation on relative change in cumulative annual dose of oral corticosteroids from the year before Baseline to the year between Baseline and 12 months visit. [Срок оценки: From the year before Baseline to the 12 months visit.]

Вторичные конечные точки (7)

• Reduction of asthma exacerbations frequency. Relative change from the year before Baseline to the year between baseline and 12 months visit in number of asthma exacerbations. [Срок оценки: From the year before Baseline to the 12 months visit.]
• Reduction of ENT events frequency. Relative change from the year before baseline to the year between baseline and 12 month visit in number of ENT events. [Срок оценки: From the year before Baseline to the 12 months visit.]
• Improvement of asthma control. Relative change from baseline to 12 months visit in ACQ-6 score [Срок оценки: Baseline and 12 months visit.]
• Improvement of chronic rhinosinusitis with nasal polyposis control . Relative change from baseline to 12 months visit in SNOT-22 score [Срок оценки: Baseline and 12 months visit.]
• Reduction in endoscopic polyp score. Relative change from baseline to 12 months visit in the polyp endoscopic score (mean of measures of both nostrils) [Срок оценки: Baseline and 12 months visit.]
• Improvement of patient's quality of life. Relative change from baseline to 12 months visit in EQ-5D-5L score [Срок оценки: Baseline and 12 months visit.]
• Reduction of healthcare ressource use . Relative change from baseline to 12 months visit in number of consultations with a specialist, general practitionner, emergency visits and hospitalizations [Срок оценки: From Baseline to the 12 months visit]

Критерии участия

Критерии включения

• Male or female, 18 years of age or older;
• With a diagnosis of asthma;
• With a diagnosis of chronic rhinosinusitis with nasal polyposis;
• Whose asthma and/or chronic rhinosinusitis is/are not controlled according to SNOT-22 and ACQ-6 scores;
• Having used systemic corticosteroids in the previous year to treat symptoms related to one of these conditions at least;

Критерии исключения

• Patient in a period of exclusion from another research protocol at the time of consent signature;
• Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (adult patients under guardianship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women);
• Patients who do not read and/or understand French

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

Франция · 1 центр

• AP-HM — Marseille

Идентификаторы

NCT: NCT07134686 · 2024-A02003-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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