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).

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Asthma; Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Treatments: Other: Joint consultation; Procedure: Mucus sampling; Procedure: Nasal brushing

Study type: Interventional

Funder types: Other

Identifiers

NCT07134686

2024-A02003-44

Details and patient eligibility

About

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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Joint consultation

Experimental group

Description:

Multi-disciplinary consultation with a pulmonologist and ENT specialist at the baseline visit

Treatment:

Procedure: Nasal brushing

Procedure: Mucus sampling

Other: Joint consultation

Separate consultations

Active Comparator group

Description:

Separate consultations with a pulmonologist and ENT specialist at the baseline visit as standard care

Treatment:

Procedure: Nasal brushing

Procedure: Mucus sampling