Health TrialsbyHealthPanel

Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy

ConditionsCystic Fibrosis (CF)Chronic Rhinosinusitis (CRS)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

The investigators are doing this study to discover if it is appropriate for people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) to stop using certain standard Sino nasal therapies such as high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. They are also going to study the fluid inside the nose to see if there are changes when stopping these therapies. Right now, they are not sure if it is suggested to stop these treatments when patients begin highly effective modulator therapy (HEMT)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Cystic Fibrosis diagnosis on HEMT

History of chronic rhinosinusitis

Using topical nasal irrigations +/- additives (steroids, antibiotics)

Disqualifiers

Below age of 18 years old

Cystic Fibrosis patient NOT on highly effective modulator therapy

Pregnant patients

Not currently using topical nasal irrigations +/- additives (steroids, antibiotics)

Trial design

Design model

Parallel

Treatments tested in this trial

  • STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

    Other intervention

    PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

  • CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

    Drug

    PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: CONTINUE TOPICAL STEROID NASAL IRRIGATIONActive comparator 1 intervention
Group B: STOP TOPICAL NASAL TREATMENTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Lund Kennedy Score

Nasal Endoscopy will be performed in the clinic to evaluate the sinonasal cavities using the Lund Kennedy scoring system. The Lund-Kennedy endoscopic score grades the severity of chronic rhinosinusitis (CRS) based on findings from five areas: polyps, discharge, edema, scarring, and crusting, with each graded on a scale of 0 to 2 for each nostril, resulting in a total possible score of 20. A higher score indicates more severe disease.

Time frame
Baseline, 12 weeks
2

Change in Pulmonary Function Testing

PULMONARY FUNCTION TESTING WILL BE PERFORMED WITH THE FEV1/FVC , CALCULATED. A lower score means poorer lung function.

Time frame
Baseline, 12 weeks
3

Change in Body Mass Index (BMI)

BMI will be calculated as weight (kg) / height (m)2

Time frame
Baseline, 12 weeks
4

Change in Health Care Utilization

Health Care Utilization will be measured though a grouped analysis for additional doctor visits, hospital admissions, and use of antibiotics and oral steroids.

Time frame
Baseline, 12 weeks

Secondary outcomes

1

Change in nasal mucous biomarkers.

A small strip of Leukosorb paper will be placed in the nostril to collect nasal mucous. The strips will be tested for the present of inflammatory markers including IL-4, IL-6, IL-8, TNF-alpha, IL-1B, Neutrophil elastase levels. The presence of inflammatory markers may indicate the return of neutrophilic infiltration.

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

American Rhinologic Society

Collaborator

Source ClinicalTrials.gov
Apply now