Pulmonary Disease, Chronic ObstructiveCOPDNCT02826954
The Nasal Airway in Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Upper airway assessment, including nasal biopsy
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients diagnosed with chronic obstructive pulmonary disease (COPD) in St Olavs Hospital, Trondheim, Norway, and healthy participants matched in age and sex.
Who may be able to join
- Diagnosis of COPD: all stages
- Healthy individuals for the control group
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Upper airway assessment, including nasal biopsy
- Keywords
- Paranasal Sinus Diseases, Nasal Obstruction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Paranasal Sinus Diseases, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper airway assessment, including nasal biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Self administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety.
Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test Receives: Other: Upper airway assessment, including nasal biopsy | |
| Healthy subjects | Self administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety.
Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test Receives: Other: Upper airway assessment, including nasal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological changes in the nose assessed with nasal endoscopy
Measured: 4 hours
inflammatory responses in the nose identified by nasal cytological brushing
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenche Thorstensen, PhD MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826954
- Sponsor's protocol ID
- 2015/2017
- Acronym
- COPD
- Status last verified
- Mar 2019
- First submitted
- 25 May 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Biobank 1
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nasal Airway in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02826954
- Acronym / sponsor ID
- COPD / 2015/2017
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Paranasal Sinus Diseases, Nasal Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, University of Copenhagen
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Upper airway assessment, including nasal biopsySelf administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety. Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test |
| Healthy subjects | – | Other: Upper airway assessment, including nasal biopsySelf administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety. Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with chronic obstructive pulmonary disease (COPD) in St Olavs Hospital, Trondheim, Norway, and healthy participants matched in age and sex.
Key inclusion criteria (2 listed)
- Diagnosis of COPD: all stages
- Healthy individuals for the control group
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper airway assessment, including nasal biopsy | Other | COPD patients, Healthy subjects |
Primary outcome
pathological changes in the nose assessed with nasal endoscopy
Time frame: 4 hours
inflammatory responses in the nose identified by nasal cytological brushing
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No. Biobank 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenche Thorstensen, PhD MD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological changes in the nose assessed with nasal endoscopy (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.