Asthma AttackNCT05603494
The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
A study testing NuvoAir in people with Asthma Attack, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Asthma Attack
- What is being tested?
- NuvoAir
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Mar 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chiung-Hung
Taoyuan, 33305
Chiung-Hung Lin, M.D., +8863281200 ext. 8470, b9502034@cgmh.org.tw
About this study
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)
Read more
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.
- Conditions
- Asthma Attack
- Being tested
- NuvoAir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvoAirDevice
Use of NuvoAir in pulmonary function monitoring during asthma attack
| Study group | Role | What they receive |
|---|---|---|
| home spirometry group | Experimental | Not described Receives: Device: NuvoAir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start29 Mar 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603494
- Sponsor's protocol ID
- 202200852B0
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 16870659Park 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.
PubMed 25553267
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Home Spirometry in the Monitoring of Patients With Acute Exacerbation of Asthma
- ClinicalTrials.gov ID
- NCT05603494
- Acronym / sponsor ID
- 202200852B0
- Conditions
- Asthma Attack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home spirometry group | Experimental | Device: NuvoAir |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvoAirUse of NuvoAir in pulmonary function monitoring during asthma attack | Device | home spirometry group |
Primary outcome
To compare between changes in asthma symptoms and pulmonary function by home spirometry
Time frame: 2 weeks
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.
1 secondary outcome
To compare the changes in daily asthma rescue medication use and pulmonary function by home spirometry
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 16870659Brouwer 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 publication: PubMed 25553267Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuvoAir in people with Asthma Attack, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare between changes in asthma symptoms and pulmonary function by home spirometry (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.