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OpenTrials
Completed

NCT Number: NCT02826954

The Nasal Airway in Chronic Obstructive Pulmonary Disease

The study is based on the theory of a "unified airway" that considers the nose and paranasal sinuses together with lower airways as one integrated unit. The upper and lower respiratory tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes in one portion of the airway, can provoke similar changes throughout the airway. This is well documented in asthmatic patients but documented poorly in patients suffering from chronic obstructive lung disease (COPD).

COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal involvement has been found to directly affect the lower airway, sinonasal disease is under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger project where the goal is to gain knowledge supporting the theory of a "unified airway" in patients with COPD.

Here sinonasal, pulmonary and generic health related quality of life will be studied in a group of patients with COPD versus a control group. The severity of nasal airway obstruction will be linked to the the severity of pulmonary airway obstruction. Assessment of pathological changes in the nose with nasal endoscopy, as well as performing a nasal cytological brushing for the identification of nasal inflammatory responses in the nose, will be conducted in both the control and study group.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD: all stages
  • Healthy individuals for the control group

Exclusion criteria

both groups:

  • asthma
  • systemic disease such as Cystic Fibrosis, Kartagener syndrome, sarcoidosis
  • upper airway infection during the last 2 weeks
  • COPD exacerbation during the last 6 weeks
  • previous surgery in the nose and paranasal sinuses
  • ongoing treatment for malignant disease
  • severe depression, Alzheimers disease and Parkinson's disease
  • pregnancy or nursing

Treatment and study plan

Upper airway assessment, including nasal biopsy

Other

Primary outcomes

  1. pathological changes in the nose assessed with nasal endoscopy

    Time frame: 4 hours

  2. inflammatory responses in the nose identified by nasal cytological brushing

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haukeland University Hospital
  • St. Olavs Hospital
  • University of Copenhagen

Registry information

Acronym: COPD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2016
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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