NCT04712799

Brief Summary

We know that there is a link between disorders in the upper and lower airways, both epidemiologically, patho-physiologically, and therapeutically. What we know less about is the role for the nose and nasal breathing for physical capacity. That goes both for the ability of the average, healthy persons well as for patients with ie. asthma and COPD to perform daily life activities as well as exercise and for top athletes to perform their maximum oxygen demanding activities. Without this knowledge, we cannot make evidence based decisions about to what extent measures to open the nose medically and/or surgically should be considered to improve physical capacity at any level. The aim of the present project is to expand our knowledge in the field for the best of the ordinary man, patients with airway disorders, and athletes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

January 13, 2021

Last Update Submit

June 23, 2023

Conditions

Keywords

noselungsphysical capacity

Outcome Measures

Primary Outcomes (1)

  • increased walking distance

    3 years

Study Arms (1)

COPD patients

EXPERIMENTAL

Wlaking tests before and afrer 1 spray with oxymetazoline

Drug: Otrivin

Interventions

oxymetazoline nasal spray

COPD patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD-

You may not qualify if:

  • Other pulmonary diseases pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sørlandet Hospital

Kristiansand, Agder, 4604, Norway

RECRUITING

Related Publications (23)

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    PMID: 31516692BACKGROUND
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    PMID: 7271065BACKGROUND
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    PMID: 7798776BACKGROUND
  • Dunlop G, Scadding GK, Lund VJ. The effect of endoscopic sinus surgery on asthma: management of patients with chronic rhinosinusitis, nasal polyposis, and asthma. Am J Rhinol. 1999 Jul-Aug;13(4):261-5. doi: 10.2500/105065899782102809.

    PMID: 10485011BACKGROUND
  • Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

    PMID: 12890299BACKGROUND
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    PMID: 10748952BACKGROUND
  • Fisher LH, Davies MJ, Craig TJ. Nasal obstruction, the airway, and the athlete. Clin Rev Allergy Immunol. 2005 Oct;29(2):151-8. doi: 10.1385/CRIAI:29:2:151.

    PMID: 16251769BACKGROUND
  • Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.

    PMID: 10559077BACKGROUND
  • Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

    PMID: 19793277BACKGROUND
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    PMID: 19347610BACKGROUND
  • Migueis DP, Thuler LC, Lemes LN, Moreira CS, Joffily L, Araujo-Melo MH. Systematic review: the influence of nasal obstruction on sleep apnea. Braz J Otorhinolaryngol. 2016 Mar-Apr;82(2):223-31. doi: 10.1016/j.bjorl.2015.05.018. Epub 2016 Jan 7.

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    PMID: 16055882BACKGROUND
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    PMID: 32665943BACKGROUND
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    PMID: 23711030BACKGROUND
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    PMID: 28153693BACKGROUND
  • Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7. doi: 10.1067/mhn.2002.121022.

    PMID: 11821764BACKGROUND
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    PMID: 16498856BACKGROUND
  • Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.

    PMID: 30846476BACKGROUND
  • Thorstensen WM, Bugten V, Sue-Chu M, Fossland NP, Romundstad PR, Steinsvag SK. Sino-nasal characteristics in asthmatic patients. Otolaryngol Head Neck Surg. 2012 Nov;147(5):950-7. doi: 10.1177/0194599812451408. Epub 2012 Jun 19.

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    PMID: 27095550BACKGROUND
  • Steinsvag SK. [Nose and lungs--two of a kind]. Tidsskr Nor Laegeforen. 2009 Oct 8;129(19):1982-4. doi: 10.4045/tidsskr.08.0394. Norwegian.

MeSH Terms

Conditions

Nasal ObstructionPulmonary Disease, Chronic Obstructive

Interventions

xylometazoline

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • sverre steinsvåg, MD, PhD

    senior consultant, professor, investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sverre steinsvåg, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

January 13, 2021

Primary Completion

January 13, 2024

Study Completion

January 13, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations