Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 10:11 AM
Study NCT ID:
NCT05603494
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: