NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP

NCT03963648 | Unknown DMC

• 1 other identifier: CRS07052019NOEKK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition resulting in varying degrees of nasal congestion, nasal secretion, facial pain and reduced or absent sense of smell. In Denmark an estimated 200.000 patients suffer from this condition. It affects the quality of life in a degree equivalent to chronic cardiac and respiratory conditions. CRSwNP is known to be associated with inflammation in the nose and sinuses. In some patients the inflammation is also present in the lower airway resulting in shortness of breath, chest constriction, wheezing and coughing. It follows that asthma is often seen in patients with CRSwNP. Even though the association of asthma and CRSwNP is well known it is easy to overlook the asthma further reducing the quality of life. Previous studies have found that undiagnosed asthma is present in about a quarter of patients with CRSwNP. While many of the CRSwNP patients are treated in private ENT practice alone the lack of simple diagnostic tests giving a reliable measurement of airway inflammation is a challenge in diagnosing concurrent asthma. A recent study showed measuring of fractional exhaled nitrogen oxide (FeNO) in exhaled air to be a promising diagnostic test. The concentration of this gas in the exhaled air from the nose and mouth is related to the degree of airway inflammation and can therefore be used as a surrogate measurement in a safe and easy way. With this study the investigators want to measure the concentration of FeNO in patients with CRSwNP in private ENT practices. The aim is to explore if it can be used as a screening test for asthma. The study will also screen the patients for obstructive sleep apnea (OSA). Patients will be recruited from three private ENT practices in the Capital Region of Denmark. Patients with CRSwNP will be recruited from their appointments in the ENT clinics. They will be offered inclusion in the study, and if they give an informed consent, an exhaled NO test and a thorough ENT examination including a fiberoptic examination of the upper airway will be performed. They will also be asked to fill out questionnaires on the severity of symptoms from the nose and lungs, sleep quality and their health in general. Patients will also undergo a sleep study (Cardio-Respiratory Monitoring = CRM) and tests of lung function. With signs of respiratory or sinus disease they will be referred for further investigations and treatment.

Conditions

Chronic Rhinosinusitis (Diagnosis); Nasal Polyps; Asthma; Obstructive Sleep Apnea; Airway Disease; Inflammatory Disease; Concomitant Disease

Outcome Measures

Primary Outcomes (1)

• Fractioned Exhaled Nitric Oxide levels (FeNO)

  Fractioned exhaled nitric oxide (FeNO) parts per billion (ppb) will be measured at an exhalation flow rate of 0.05 L/s, during single exhalation, using a portable nitric oxide analyzer device (NIOX VERO, Circassia AB, P.O. Box 3006 SE-750 03 Uppsala, Sweden). The normal exhaled NO values during measurements will be set to 5-35 ppb for healthy adults. Patients must produce a 10-second exhalation of breath at an exhalation pressure of 10-20 cmH2O to maintain a stable flow rate of 50±5 mL/s. A calibrated electrochemical sensor evaluates the final 3 seconds of exhalation expressing results in ppb with a range between 5 ppb and 300 ppb. The higher the measurement the larger is the risk of airway inflammation.

  3 years

Secondary Outcomes (7)

• Nasal Nitric Oxide levels (nNO)

  3 years

• Apnea Hypopnea Index (AHI)

  3 years

• Forced Expiratory Volume in 1 second (FEV1)

  3 years

• Sino Nasal Outcome Test (questionnaire)

  3 years

• Epworth Sleepiness Scale (questionnaire)

  3 years

Study Arms (1)

CRSwNP

EXPERIMENTAL

Study group that will undergo fractioned exhaled nitrogen oxide measurements as well as tests of lungfunction and sleep studies. All tests are non-invasive.

Diagnostic Test: Fractioned Exhaled Nitrogen Oxide measurements

Interventions

Fractioned Exhaled Nitrogen Oxide measurements DIAGNOSTIC_TEST

Measurements of Fractioned Exhaled Nitrogen Oxide obtained by blowing into a mouthpiece. The NIOX VERO machine will be used for these measures.

CRSwNP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CRSwNP based on the EPOS2012 criteria
• Polyps in both sides of the nose verified by fiberoptic examination of the nasal cavities

You may not qualify if:

• Treatment with systemic steroids in the course of the last three months
• Treatment with topical steroids in the course of the last two weeks
• Other inflammatory diseases of the upper airways (i.e. cystic fibrosis, primary ciliary dyskinesis) or immune deficiencies, sarcoidosis or systemic vasculitis
• Infections in the upper airway during the past two weeks
• Smokers
• Treatment with antidepressant or sedative drugs
• Age below 18
• Patients unable to give an informed consent
• Patients that do not speak or read Danish

Sponsors & Collaborators

• Christian von Buchwald: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Disease; Nasal Polyps; Asthma; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Eva K Kiær

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva K Kiaer, M.D.

CONTACT

+45 35 45 66 35; eva.kirkegaard.kiaer.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 28, 2019
• Study Start: September 13, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)