{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T22:27:55Z","timestamp":1762900075129,"version":"build-2065373602"},"reference-count":34,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,2,12]],"date-time":"2021-02-12T00:00:00Z","timestamp":1613088000000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,2,3]]},"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off &gt;50 ppb (parts per billion) is suitable for diagnosing asthma (sensitivity 35%, specificity 95%); (2) If the clinical symptoms \u2018allergic rhinitis\u2019 and \u2018wheezing\u2019 are present, asthma can be diagnosed at FeNO &gt;33 ppb with a positive predictive value (PPV) <jats:underline>&gt;<\/jats:underline>70% and (3) A FeNO &gt;33 ppb can predict responsiveness to inhaled corticosteroid (ICS) with a PPV <jats:underline>&gt;<\/jats:underline>70%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>A prospective diagnostic study will be conducted in three practices of pneumologists in Germany. 300 patients suspected of suffering from asthma will be included. As an index test, patients perform FeNO measurement with the device NIOX VERO. As reference a test, patients are examined with whole bodyplethysmography and BP, if necessary. After 3 months, patients with an asthma diagnosis will be examined again to verify the diagnosis and evaluate ICS responsiveness. Patients who did not receive an asthma diagnosis at the initial examination will be phoned after 3 months and asked about persistent respiratory symptoms to exclude false negative findings. As a primary target, sensitivity and specificity of FeNO &gt;50 ppb will be determined. As a secondary target the PPV for asthma at FeNO &gt;33 ppb, when the symptoms \u2018allergic rhinitis\u2019 and \u2018wheezing\u2019 are present, will be calculated. Regarding ICS responsiveness, the PPV of FeNO &gt;33 ppb will be determined.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The study was approved by the Ethical Committee of the Technical University of Munich (Reference number 122\/20 S). The major results will be published in peer-reviewed academic journals and disseminated through conferences.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>DRKS00021125.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045420","type":"journal-article","created":{"date-parts":[[2021,2,12]],"date-time":"2021-02-12T12:59:58Z","timestamp":1613134798000},"page":"e045420","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0670-6392","authenticated-orcid":false,"given":"Christina","family":"Kellerer","sequence":"first","affiliation":[{"name":"Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Hapfelmeier","sequence":"additional","affiliation":[{"name":"Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany"},{"name":"Institute of Medical Informatics, Statistics and Epidemiology, School of Medicine, Technical University of Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rudolf A","family":"J\u00f6rres","sequence":"additional","affiliation":[{"name":"Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Konrad","family":"Schultz","sequence":"additional","affiliation":[{"name":"Clinic Bad Reichenhall, Center for Rehabilitation, Pneumology and Orthopedics, Bad Reichenhall, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Brunn","sequence":"additional","affiliation":[{"name":"Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonius","family":"Schneider","sequence":"additional","affiliation":[{"name":"Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,2,12]]},"reference":[{"key":"2025101812272984000_11.2.e045420.1","unstructured":"Bundes\u00e4rztekammer (B\u00c4K), Kassen\u00e4rztliche Bundesvereinigung (KBV), Arbeitsgemeinschaft Der Wissenschaftli-chen Medizinischen Fachgesellschaften (AWMF) . 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