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

Primary Purpose

Asthma Attack

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NuvoAir
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma Attack

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chiung-HungRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

home spirometry group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2022
Last Updated
September 5, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05603494
Brief Title
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
Official Title
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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

5. 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: 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 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
home spirometry group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NuvoAir
Intervention Description
Use of NuvoAir in pulmonary function monitoring during asthma attack
Primary Outcome Measure Information:
Title
To compare between changes in asthma symptoms and pulmonary function by home spirometry
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry
Description
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.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
To compare the degree of discrepancy between different asthma phenotypes
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chiung-Hung
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiung-Hung Lin, M.D.
Phone
+8863281200
Ext
8470
Email
b9502034@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16870659
Citation
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.
Results Reference
result
PubMed Identifier
25553267
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 2014 Nov 25.
Results Reference
result

Learn more about this trial

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

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