Primary Care Asthma FeNO Trial

NCT05853809 | Completed

• 1 other identifier: 2020-00919
• Study Type: interventional
• Target: 3,254
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic inflammatory respiratory disease that affects people of all ages and of both sexes. It is a common disease and is present in 8-10 % of the population. Despite drug treatment, many patients have poor control of their asthma with an impact on quality of life and restriction of daily activities. The purpose of this study in primary care is to investigate if measurement of airway inflammation (FeNO) can improve the treatment results and the overall care of adult patients with asthma. The main question in the study is whether the use of FeNO measurements can reduce the number of deterioration periods. The study is conducted under real clinical conditions where the effect of the intervention is measured (pragmatic intervention study). Eight to twelve primary health care centers with functional asthma / COPD clinics are selected within the Stockholm County and are randomly assigned to two groups with four to six primary health care centers each, an active group and a control group (cluster randomization). Instruments for FeNO measurements are made available to the active group and this group is also trained on FeNO measurements and how the value should be interpreted and used to control the treatment, while the control group continues to take care of their asthma patients as usual. The study can lead to improved treatment decisions and patients gaining an increased understanding of their asthma by being informed on the actual degree of inflammation in the airways. Optimized treatment can provide better asthma control with increased quality of life and fewer periods of deterioration, which results in reduced burden on healthcare and lower costs for patients and society.

Conditions

Asthma

Keywords

Exhaled nitric oxide; FeNO; Exacerbations; Asthma control

Outcome Measures

Primary Outcomes (1)

• Exacerbation rate

  Can use of FeNO measurements decrease the number of exacerbations compared to usual care.

  Two years

Secondary Outcomes (4)

• Asthma control

  Two years

• Lung function

  Two years

• Use of short-acting β2 receptor agonists

  Two years

• Total cost of asthma medications

  Two years

Study Arms (2)

FeNO measurement

ACTIVE COMPARATOR

Anti inflammatory treatment guided by measurement of airway inflammation (FeNO).

Diagnostic Test: FeNO measurement

Usual care

NO INTERVENTION

Interventions

FeNO measurement DIAGNOSTIC_TEST

FeNO measurement to guide anti-inflammatory asthma treatment

FeNO measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosed asthma according to medical record.
• Patients seeking advice for symptoms suggestive of asthma

You may not qualify if:

• Physician diagnosed COPD (Chronic Obstructive Pulmonary Disease) according to medical record.

Sponsors & Collaborators

• Region Stockholm: lead
• Uppsala University: collaborator
• Karolinska Institutet: collaborator
• Universidade do Porto: collaborator
• Niox Group Plc: collaborator

Study Sites (1)

Region Stockholm

Stockholm, Sweden

Location

Related Publications (14)

• Nathan RA, Meltzer EO, Blaiss MS, Murphy KR, Doherty DE, Stoloff SW. Comparison of the Asthma in America and Asthma Insight and Management surveys: did asthma burden and care improve in the United States between 1998 and 2009? Allergy Asthma Proc. 2012 Jan-Feb;33(1):65-76. doi: 10.2500/aap.2011.32.3521. Epub 2011 Dec 15.

  PMID: 22309828 BACKGROUND

• Stallberg B, Lisspers K, Hasselgren M, Janson C, Johansson G, Svardsudd K. Asthma control in primary care in Sweden: a comparison between 2001 and 2005. Prim Care Respir J. 2009 Dec;18(4):279-86. doi: 10.4104/pcrj.2009.00024.

  PMID: 19455269 BACKGROUND

• Alving K, Weitzberg E, Lundberg JM. Increased amount of nitric oxide in exhaled air of asthmatics. Eur Respir J. 1993 Oct;6(9):1368-70.

  PMID: 7507065 BACKGROUND

• Malinovschi A, Fonseca JA, Jacinto T, Alving K, Janson C. Exhaled nitric oxide levels and blood eosinophil counts independently associate with wheeze and asthma events in National Health and Nutrition Examination Survey subjects. J Allergy Clin Immunol. 2013 Oct;132(4):821-7.e1-5. doi: 10.1016/j.jaci.2013.06.007. Epub 2013 Jul 26.

  PMID: 23890753 BACKGROUND

• Pavord ID, Bafadhel M. Exhaled nitric oxide and blood eosinophilia: independent markers of preventable risk. J Allergy Clin Immunol. 2013 Oct;132(4):828-9. doi: 10.1016/j.jaci.2013.07.045. Epub 2013 Aug 31. No abstract available.

  PMID: 24001802 BACKGROUND

• Sverrild A, Malinovschi A, Porsbjerg C, Backer V, Alving K. Predicting airway hyperreactivity to mannitol using exhaled nitric oxide in an unselected sample of adolescents and young adults. Respir Med. 2013 Jan;107(1):150-2. doi: 10.1016/j.rmed.2012.09.004. Epub 2012 Nov 21.

  PMID: 23177390 BACKGROUND

• Price DB, Buhl R, Chan A, Freeman D, Gardener E, Godley C, Gruffydd-Jones K, McGarvey L, Ohta K, Ryan D, Syk J, Tan NC, Tan T, Thomas M, Yang S, Konduru PR, Ngantcha M, d'Alcontres MS, Lapperre TS. Fractional exhaled nitric oxide as a predictor of response to inhaled corticosteroids in patients with non-specific respiratory symptoms and insignificant bronchodilator reversibility: a randomised controlled trial. Lancet Respir Med. 2018 Jan;6(1):29-39. doi: 10.1016/S2213-2600(17)30424-1. Epub 2017 Nov 3.

  PMID: 29108938 BACKGROUND

• Nolte H, Pavord I, Backer V, Spector S, Shekar T, Gates D, Nair P, Hargreave F. Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma. Respir Med. 2013 May;107(5):656-64. doi: 10.1016/j.rmed.2013.02.010. Epub 2013 Mar 13.

  PMID: 23490226 BACKGROUND

• Syk J, Unden AL, Alving K. Relationship between exhaled nitric oxide and IgE sensitisation in patients with asthma: influence of steroid treatment. Clin Respir J. 2009 Jul;3(3):143-51. doi: 10.1111/j.1752-699X.2008.00124.x.

  PMID: 20298397 BACKGROUND

• Syk J, Malinovschi A, Johansson G, Unden AL, Andreasson A, Lekander M, Alving K. Anti-inflammatory treatment of atopic asthma guided by exhaled nitric oxide: a randomized, controlled trial. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):639-48.e1-8. doi: 10.1016/j.jaip.2013.07.013. Epub 2013 Oct 9.

  PMID: 24565712 BACKGROUND

• Petsky HL, Cates CJ, Kew KM, Chang AB. Tailoring asthma treatment on eosinophilic markers (exhaled nitric oxide or sputum eosinophils): a systematic review and meta-analysis. Thorax. 2018 Dec;73(12):1110-1119. doi: 10.1136/thoraxjnl-2018-211540. Epub 2018 Jun 1.

  PMID: 29858277 BACKGROUND

• Syk J, Malinovschi A, Borres MP, Unden AL, Andreasson A, Lekander M, Alving K. Parallel reductions of IgE and exhaled nitric oxide after optimized anti-inflammatory asthma treatment. Immun Inflamm Dis. 2016 Mar 21;4(2):182-190. doi: 10.1002/iid3.103. eCollection 2016 Jun.

  PMID: 27933161 BACKGROUND

• Zeiger RS, Schatz M, Yang SJ, Chen W. Fractional Exhaled Nitric Oxide-Assisted Management of Uncontrolled Persistent Asthma: A Real-World Prospective Observational Study. Perm J. 2019;23:18-109. doi: 10.7812/TPP/18-109.

  PMID: 31050641 BACKGROUND

• Jacinto T, Amaral R, Malinovschi A, Janson C, Fonseca J, Alving K. Exhaled NO reference limits in a large population-based sample using the Lambda-Mu-Sigma method. J Appl Physiol (1985). 2018 Nov 1;125(5):1620-1626. doi: 10.1152/japplphysiol.00093.2018. Epub 2018 Aug 30.

  PMID: 30161011 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jörgen Syk, MD PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Postgraduate Studies, Intern and Resident Physicians

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: April 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)