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

NCT ID: NCT05603494

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2024-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Attack

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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home spirometry group

Group Type EXPERIMENTAL

NuvoAir

Intervention Type DEVICE

Use of NuvoAir in pulmonary function monitoring during asthma attack

Interventions

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NuvoAir

Use of NuvoAir in pulmonary function monitoring during asthma attack

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chiung-Hung

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chiung-Hung Lin, M.D.

Role: primary

+8863281200 ext. 8470

References

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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.

Reference Type RESULT
PMID: 16870659 (View on PubMed)

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.

Reference Type RESULT
PMID: 25553267 (View on PubMed)

Other Identifiers

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202200852B0

Identifier Type: -

Identifier Source: org_study_id

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