Cluster-Randomized Asthma FeNO Trial

NCT05853809 | Unknown

• 1 other identifier: 2020-00919
• Study Type: interventional
• Target: 3,000
• 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

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: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)