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).

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Joint consultation

    Other intervention

    Joint consultation with pneumologist and ENT at baseline.

  • Mucus sampling

    Procedure/Surgery

    Mucus sampling at baseline and one year follow-up

  • Nasal brushing

    Procedure/Surgery

    Nasal brushing at baseline and one year follow-up

Treatment groups

195 Participants
are divided into 2 treatment groups
Group A: Joint consultationExperimental treatment 3 interventions
Group B: Separate consultationsActive comparator 2 interventions

Trial outcomes

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.

Time frame
From the year before Baseline to the 12 months visit.

Secondary outcomes

1

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.

self-reported number of asthma exacerbations

Time frame
From the year before Baseline to the 12 months visit.
2

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.

Self reported number of ENT events

Time frame
From the year before Baseline to the 12 months visit.
3

Improvement of asthma control. Relative change from baseline to 12 months visit in ACQ-6 score

Self-administered questionnaire

Time frame
Baseline and 12 months visit.
4

Improvement of chronic rhinosinusitis with nasal polyposis control . Relative change from baseline to 12 months visit in SNOT-22 score

Self-administered questionnaire

Time frame
Baseline and 12 months visit.

Other outcomes

Sponsors and contacts

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