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The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma

NCT05603494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-07

No results posted yet for this study

Summary

After outpatient clinic visit, asthmatic patients with worsening of symptoms (including dyspnea, wheezing, chest tightness, cough, activity limitation, awaken in the midnight due to discomfort) and are diagnosed of acute exacerbation by physician, will be recruited. The patients are asked to record symptoms using asthma symptom diary (ASD) with home spirometry simultaneously for 14 days.

Visit 1 (day 1)

All patients will be evaluated the following:

1. Record the patients' demographics (age, gender, race), baseline characteristics, comorbidities, health care resources use (visits, lab tests, hospitalization and cost), pharmacological and non-pharmacological treatments
2. Blood sampling for eosinophils, eosinophil cationic protein (ECP) and immunoglobulin E (IgE) as clinically indicated (if no data available within one year for the last two)
3. The study assistant will introduce to the patient how to manipulate the home spirometry and its app, and to record the daily asthma symptoms by using the ASD on the mobile phone.

Visit 2 (day 15) All patients will be arranged outpatient clinic follow up 2 weeks later from the first visit. The outpatient clinic physician will check the home spirometry report and ASD symptom score in the past 2 weeks, and have a well explanation of these results.

Statistical analysis The usage of digital function including input ASD, and the lung function from portable spirometer in study arm will be demonstrated by descriptive statistics.

Conditions

  • Asthma Attack

Interventions

DEVICE

NuvoAir

Use of NuvoAir in pulmonary function monitoring during asthma attack

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603494 on ClinicalTrials.gov