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).

NCT ID: NCT07134686

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-11-30

Brief Summary

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.

Conditions

Asthma; Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Joint consultation

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

Group Type: EXPERIMENTAL

Joint consultation

Intervention Type: OTHER

Joint consultation with pneumologist and ENT at baseline.

Mucus sampling

Intervention Type: PROCEDURE

Mucus sampling at baseline and one year follow-up

Nasal brushing

Intervention Type: PROCEDURE

Nasal brushing at baseline and one year follow-up

Separate consultations

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

Group Type: ACTIVE_COMPARATOR

Mucus sampling

Intervention Type: PROCEDURE

Mucus sampling at baseline and one year follow-up

Nasal brushing

Intervention Type: PROCEDURE

Nasal brushing at baseline and one year follow-up

Interventions

Joint consultation

Joint consultation with pneumologist and ENT at baseline.

Intervention Type: OTHER

Mucus sampling

Mucus sampling at baseline and one year follow-up

Intervention Type: PROCEDURE

Nasal brushing

Nasal brushing at baseline and one year follow-up

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024-A02003-44

Identifier Type: -

Identifier Source: org_study_id