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).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Joint consultation, Mucus sampling, Nasal brushing.
- Who it may be relevant to
- Registry conditions: Asthma, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Joint consultation
Joint consultation with pneumologist and ENT at baseline. - Procedure Mucus sampling
Mucus sampling at baseline and one year follow-up - Procedure Nasal brushing
Nasal brushing at baseline and one year follow-up
Primary outcome measures
- 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. [Time frame: From the year before Baseline to the 12 months visit.]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: From Baseline to the 12 months visit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- AP-HM — Marseille
Identifiers
NCT: NCT07134686 · 2024-A02003-44