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Nasal Breathing and Physical Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04712799
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sverre Steinsvåg, Sorlandet Hospital HF

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.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Copd Drug: Otrivin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of the Nose for Physical Capacity
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : January 13, 2024
Estimated Study Completion Date : January 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: COPD patients
Wlaking tests before and afrer 1 spray with oxymetazoline
Drug: Otrivin
oxymetazoline nasal spray




Primary Outcome Measures :
  1. increased walking distance [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

COPD-

Exclusion Criteria:

  • Other pulmonary diseases pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712799


Contacts
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Contact: sverre steinsvåg, MD, PhD 95880342 sverre.steinsvag@sshf.no

Locations
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Norway
Sørlandet Hospital Recruiting
Kristiansand, Agder, Norway, 4604
Contact: sverre steinsvåg, MD, PhD    95880342    sverre.steinsvag@sshf.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Principal Investigator: sverre steinsvåg, MD, PhD senior consultant, professor, investigator
Publications of Results:
Other Publications:
Bousquet JJ, Schünemann HJ, Togias A, Erhola M, Hellings PW, Zuberbier T, Agache I, Ansotegui IJ, Anto JM, Bachert C, Becker S, Bedolla-Barajas M, Bewick M, Bosnic-Anticevich S, Bosse I, Boulet LP, Bourrez JM, Brusselle G, Chavannes N, Costa E, Cruz AA, Czarlewski W, Fokkens WJ, Fonseca JA, Gaga M, Haahtela T, Illario M, Klimek L, Kuna P, Kvedariene V, Le LTT, Larenas-Linnemann D, Laune D, Lourenço OM, Menditto E, Mullol J, Okamoto Y, Papadopoulos N, Pham-Thi N, Picard R, Pinnock H, Roche N, Roller-Wirnsberger RE, Rolland C, Samolinski B, Sheikh A, Toppila-Salmi S, Tsiligianni I, Valiulis A, Valovirta E, Vasankari T, Ventura MT, Walker S, Williams S, Akdis CA, Annesi-Maesano I, Arnavielhe S, Basagana X, Bateman E, Bedbrook A, Bennoor KS, Benveniste S, Bergmann KC, Bialek S, Billo N, Bindslev-Jensen C, Bjermer L, Blain H, Bonini M, Bonniaud P, Bouchard J, Briedis V, Brightling CE, Brozek J, Buhl R, Buonaiuto R, Canonica GW, Cardona V, Carriazo AM, Carr W, Cartier C, Casale T, Cecchi L, Cepeda Sarabia AM, Chkhartishvili E, Chu DK, Cingi C, Colgan E, de Sousa JC, Courbis AL, Custovic A, Cvetkosvki B, D'Amato G, da Silva J, Dantas C, Dokic D, Dauvilliers Y, Dedeu A, De Feo G, Devillier P, Di Capua S, Dykewickz M, Dubakiene R, Ebisawa M, El-Gamal Y, Eller E, Emuzyte R, Farrell J, Fink-Wagner A, Fiocchi A, Fontaine JF, Gemicioğlu B, Schmid-Grendelmeir P, Gamkrelidze A, Garcia-Aymerich J, Gomez M, González Diaz S, Gotua M, Guldemond NA, Guzmán MA, Hajjam J, O'B Hourihane J, Humbert M, Iaccarino G, Ierodiakonou D, Illario M, Ivancevich JC, Joos G, Jung KS, Jutel M, Kaidashev I, Kalayci O, Kardas P, Keil T, Khaitov M, Khaltaev N, Kleine-Tebbe J, Kowalski ML, Kritikos V, Kull I, Leonardini L, Lieberman P, Lipworth B, Lodrup Carlsen KC, Loureiro CC, Louis R, Mair A, Marien G, Mahboub B, Malva J, Manning P, De Manuel Keenoy E, Marshall GD, Masjedi MR, Maspero JF, Mathieu-Dupas E, Matricardi PM, Melén E, Melo-Gomes E, Meltzer EO, Menditto E, Mercier J, Miculinic N, Mihaltan F, Milenkovic B, Moda G, Mogica-Martinez MD, Mohammad Y, Montefort S, Monti R, Morais-Almeida M, Mösges R, Münter L, Muraro A, Murray R, Naclerio R, Napoli L, Namazova-Baranova L, Neffen H, Nekam K, Neou A, Novellino E, Nyembue D, O'Hehir R, Ohta K, Okubo K, Onorato G, Ouedraogo S, Pali-Schöll I, Palkonen S, Panzner P, Park HS, Pépin JL, Pereira AM, Pfaar O, Paulino E, Phillips J, Picard R, Plavec D, Popov TA, Portejoie F, Price D, Prokopakis EP, Pugin B, Raciborski F, Rajabian-Söderlund R, Reitsma S, Rodo X, Romano A, Rosario N, Rottem M, Ryan D, Salimäki J, Sanchez-Borges MM, Sisul JC, Solé D, Somekh D, Sooronbaev T, Sova M, Spranger O, Stellato C, Stelmach R, Suppli Ulrik C, Thibaudon M, To T, Todo-Bom A, Tomazic PV, Valero AA, Valenta R, Valentin-Rostan M, van der Kleij R, Vandenplas O, Vezzani G, Viart F, Viegi G, Wallace D, Wagenmann M, Wang Y, Waserman S, Wickman M, Williams DM, Wong G, Wroczynski P, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zeng S, Zernotti M, Zhang L, Zhong NS, Zidarn M; ARIA Study Group; MASK Study Group. Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases. Clin Transl Allergy. 2019 Sep 9;9:44. doi: 10.1186/s13601-019-0279-2. eCollection 2019. Review.

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Responsible Party: Sverre Steinsvåg, MD, PhD, professor, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT04712799    
Other Study ID Numbers: SorlandetHF steinsvåg
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sverre Steinsvåg, Sorlandet Hospital HF:
nose
lungs
physical capacity
Additional relevant MeSH terms:
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Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Xylometazoline
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents