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).

NCT07134686 | Not Yet Recruiting

• 1 other identifier: 2024-A02003-44
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Asthma; Care pathway; Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Self reported cumulative annual dose of oral corticosteroids.

  From the year before Baseline to the 12 months visit.

Secondary Outcomes (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.

  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.

  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

  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

  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)

  Baseline and 12 months visit.

Study Arms (2)

Joint consultation

EXPERIMENTAL

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

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

Separate consultations

ACTIVE COMPARATOR

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

Procedure: Mucus sampling; Procedure: Nasal brushing

Interventions

Joint consultation OTHER

Joint consultation with pneumologist and ENT at baseline.

Joint consultation

Mucus sampling PROCEDURE

Mucus sampling at baseline and one year follow-up

Joint consultation; Separate consultations

Nasal brushing PROCEDURE

Nasal brushing at baseline and one year follow-up

Joint consultation; Separate consultations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09