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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05603494
Collaborator
(none)
50
1
1
8
6.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: NuvoAir
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
Anticipated Study Start Date :
Oct 28, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: home spirometry group

Device: NuvoAir
Use of NuvoAir in pulmonary function monitoring during asthma attack

Outcome Measures

Primary Outcome Measures

  1. To compare between changes in asthma symptoms and pulmonary function by home spirometry [2 weeks]

    To compare between changes in asthma symptoms by asthma symptom diary (scoring in points) and changes in forced expiratory volume in 1 second (FEV1, in liters) in patients with acute exacerbation of asthma. Asthma symptom diary (ASD) consist of daytime and nighttime score will be recorded everyday over the 14-day study period.

Secondary Outcome Measures

  1. To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry [2 weeks]

    To compare between changes in the daily inhalation times (puffs in times per day) and changes in forced expiratory volume in 1 second (FEV1, in liters) in patients with acute exacerbation of asthma. Rescue medication (Fenoterol, Albuterol, inhaled corticosteroid-formoterol) use was measured by the number of inhalations per day.

Other Outcome Measures

  1. To compare the degree of discrepancy between different asthma phenotypes [2 weeks]

    To compare between changes in asthma symptoms (scoring in points) and forced expiratory volume in 1 second (FEV1, in liters) in patients with acute exacerbation of asthma in different asthma phenotypes (allergic type, non-allergic T2 type, non-T2 type).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 20 to 75 years old asthmatic patients under regular treatment for at least 3 months.

  • Patients in asthma acute exacerbation (symptoms onset within 1 week) and received oral corticosteroid for more than 3 days.

Exclusion Criteria:
  • Refuse to provide inform consent.

  • Patients with chronic obstructive pulmonary disease.

  • Patients who receive more than 20mg prednisone or equivalent dose per day.

  • Patients who are incapable of using smart phone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chiung-Hung Taoyuan Taiwan 33305

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05603494
Other Study ID Numbers:
  • 202200852B0
First Posted:
Nov 2, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2022