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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05603494
Other study ID # 202200852B0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2023
Est. completion date July 30, 2024

Study information

Verified date September 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Chiung-Hung Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Brouwer AF, Roorda RJ, Brand PL. Home spirometry and asthma severity in children. Eur Respir J. 2006 Dec;28(6):1131-7. doi: 10.1183/09031936.06.00118205. Epub 2006 Jul 26. — View Citation

Park SY, Yoon SY, Shin B, Kwon HS, Kim TB, Moon HB, Cho YS. Clinical factors affecting discrepant correlation between asthma control test score and pulmonary function. Allergy Asthma Immunol Res. 2015 Jan;7(1):83-7. doi: 10.4168/aair.2015.7.1.83. Epub 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other To compare the degree of discrepancy between different asthma phenotypes 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). 2 weeks
Primary To compare between changes in asthma symptoms and pulmonary function by home spirometry 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.
2 weeks
Secondary To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry 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.
2 weeks
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