NCT06272773

Brief Summary

Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma. FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres. However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT. Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function. We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 16, 2024

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in airway resistance at 5 Hertz (Hz) and 19Hz

    To assess the affect of a change in breathing frequency on FOT measurements, specifically airway resistance at 5Hz and 19Hz, in patients with a known diagnosis of asthma.

    20 mins

Interventions

Participant will breathe normally through the device which sends different frequency sounds into the airways, monitoring the response coming back from central and peripheral airways to calculate airway impedence, reactance and resistance.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with physician-diagnosed asthma and demonstrable obstructive lung disease.

You may qualify if:

  • Age \> 18years Confirmed diagnosis of asthma Evidence of obstructive lung disease, FEV1/forced vital capacity (FVC) \<lower limit of normal (LLN)

You may not qualify if:

  • Unstable/Uncontrolled asthma, as designated by the patient's consultant Known breathing pattern disorder Inability to cooperate with instructions Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Healthcare Scientist

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 22, 2024

Study Start

March 1, 2024

Primary Completion

October 1, 2024

Study Completion

March 1, 2025

Last Updated

February 22, 2024

Record last verified: 2024-02