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

NCT05603494 | Unknown FDA Device

• 1 other identifier: 202200852B0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Asthma Attack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry

  2 weeks

Other Outcomes (1)

• To compare the degree of discrepancy between different asthma phenotypes

  2 weeks

Study Arms (1)

home spirometry group

EXPERIMENTAL

Device: NuvoAir

Interventions

NuvoAir DEVICE

Use of NuvoAir in pulmonary function monitoring during asthma attack

home spirometry group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chiung-Hung

Taoyuan District, 33305, Taiwan

RECRUITING

Related 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.

  PMID: 16870659 RESULT

• 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.

  PMID: 25553267 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: November 2, 2022
• Study Start: March 29, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

TW (1)