Moderate AsthmaLEARNNCT05757908
Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist
A study testing Long-Acting Beta Agonist in people with Moderate Asthma, run by Koneksa Health at 9 sites in United States.
Trial summary
The goal of this interventional study is to compare at-home mobile spirometry to in-clinic spirometry in participants with moderate asthma while taking a long-acting beta agonist (LABA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Asthma
- What is being tested?
- Long-Acting Beta Agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Apr 2023to 29 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 18 years or older
- Body mass index (BMI) 18 - 40 mg/m2 inclusive
- Participant with a diagnosis of moderate uncontrolled asthma
- Participant must be using a medium to high daily dose of inhaled corticosteroids (ICS) for a minimum of 6 weeks prior to screening
- Asthma that is not currently using long-acting beta-agonists (LABA) or log-acting muscarinic antagonist (LAMA) (ACQ score of 0.75 or higher) Note: A 2-week LABA/LAMA washout period is allowed prior to screening
- Pre-bronchodilator FEV1 ≥ 60% and ≤100% of the predicted normal values at screening
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- A documented positive response to the reversibility test at screening, defined as improvement in FEV1 ≥ 12% and ≥ 200 mL over baseline after a Short Acting Beta Agonist (SABA) standard of care dose. Documented historical reversibility of up to 6 weeks is allowed.
- Participant is judged to be in good health based on medical history, physical examination, and vital sign measurements
- Non-smokers or ex-smokers (including vape or inhaled cannabis) who have stopped smoking more than 1 year ago
- Women of childbearing potential must have a negative urine pregnancy test before enrolling at Baseline Day 1
- Participant demonstrated ability to perform satisfactory in-clinic and at-home Spirometry according to ATS/ERS standards, as well as the mobile application to synchronize Spirometry data collection and respond to questionnaires during the Screening coaching/training period
Who cannot join
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures or hospitalization (including ER visits) for the treatment of asthma within 3 months prior to screening, or have been hospitalized or have attended the ER for asthma more than twice in prior 6 months
- Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to Screening
- History of substance abuse in the last 6 months, excluding medical or recreational non- inhaled marijuana
- Currently taking other biologics to control asthma symptoms (allergy shots are acceptable)
- Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; or other lung diseases (e.g., emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease)
- Clinically unstable participants or history of non-compliance as assessed by the PI
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- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening
- Participant has a history of neoplastic disease. Exceptions: Participants with (1) an adequately treated basal or squamous cell carcinoma or carcinoma in situ of the cervix; (2) localized or regional prostate cancer; other malignancies which have been successfully treated > 5 years prior to screening without evidence of recurrence may participate
- Participants treated with oral or parenteral corticosteroids in the previous 4 weeks prior to screening
- You may not be able to participate in this study if you have been in another investigational drug study for 30 days prior to this study unless approval is given from the Sponsor. Additionally, you cannot be involved in another investigational drug study during your participation in this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Asthma & Allergy Center, PC
Bellevue, Nebraska, 68123
AllerVie Research Clinic
Birmingham, Alabama, 35209
American Health Research
Charlotte, North Carolina, 28277
AllerVie Research Clinic
Columbus, Georgia, 31904
El Paso Pulmonary Association
El Paso, Texas, 79902
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
South Texas Allergy & Asthma Medical Professionals Research
San Antonio, Texas, 78229
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: An Open-Label, Single-Arm Study in Moderate Asthma Participants Comparing the Treatment With Long-Acting Beta Agonist Between At-Home Mobile Spirometry and In-Clinic Spirometry (LEARN)
The goal of this interventional study is to compare at-home mobile spirometry to in-clinic spirometry in participants with moderate asthma while taking a long-acting beta agonist (LABA).
The main questions it aims to answer are:
Read more
- Do at-home mobile spirometry and in-clinic spirometry assessments show a similar treatment effect (measured changes in FEV1) with the addition of LABA?
- Is at-home mobile spirometry as accurate as in-clinic spirometry in showing treatment effects (changes in FEV1)?
Participants will be asked to:
- Take standard of care LABA treatment once or twice a day
- Complete at-home mobile spirometry testing twice a day
- Complete asthma questionnaires twice a day
- Complete device use questionnaires
- Wear a wrist device (like a watch) to track physical activity and vital signs
- Visit the clinic for in-clinic spirometry testing once a week for 8 weeks
Read the detailed description
The study will recruit up to 60 participants with moderate uncontrolled asthma who are taking inhaled corticosteroids (ICS) at the time of study enrollment but will require LABA treatment as judged by their treating physician. The study will assess the LABA treatment effect in clinic and mobile spirometry, assess the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, patient reported outcome questionnaire. Additional objectives include an evaluation of patient and site-specific satisfaction with mobile spirometry technology.
The study consists of a one-week screening period, one-week baseline period, and up to 6-week interventional assessment period consisting of addition of LABA, for an estimated participant duration of 8 weeks.
- Conditions
- Moderate Asthma
- Being tested
- Long-Acting Beta Agonist
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Acting Beta AgonistDrug
Also called LABA
The Investigator will prescribe standard of care LABA to eligible study participants. Participants will self-administer LABA once or twice daily at the maximum feasible standard of care dosage, per the time points specified in the study Schedule of Assessments. LABA should be taken within 1 to 3 hours prior to morning and evening at-home mobile Spirometry testing.
| Study group | Role | What they receive |
|---|---|---|
| Long-Acting Beta Agonist | Other | Standard of care LABA Receives: Drug: Long-Acting Beta Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured FEV1 Change to Treatment Effect
Detection of treatment effect as measured by change from baseline in morning FEV1 measured in change over time for at-home mobile and in-clinic Spirometry
Measured: Baseline Day 1 through Day 43 End of Study
Measured FEV1 Change and Comparison of Variability
Change from baseline and comparison of variability (measured via confidence interval) in morning FEV1 for at-home morning mSpirometry compared to morning in-clinic Spirometry
Measured: Baseline Day 1 through Day 43 End of Study
Secondary outcomes (7)
Mobile Spirometry Compliance
Percentage of compliance for once and twice daily at-home mSpirometry
Measured: Baseline Day 1 through Day 43 End of Study
Relationship Between In-clinic and Mobile Spirometry Parameters
- Evaluate the relationship between in-clinic and mSpirometry FEV1 and other Spirometry parameters (e.g., FVC)
- Relationship between other Spirometry measurements (e.g., FVC)
Measured: Baseline Day 1 through Day 43 End of Study
Diurnal Differences in Mobile Spirometry
Diurnal differences in morning versus evening for at-home mSpirometry parameters, e.g., FEV1
Measured: Baseline Day 1 through Day 43 End of Study
Time to Treatment Effect
Time to treatment effect detection using at-home mSpirometry via change in FEV1
Measured: Baseline Day 1 through Day 43 End of Study
Treatment Effect
Treatment effect as measured by change from baseline in ACQ-6
Measured: Baseline Day 1 through Day 43 End of Study
Mobile Spirometry Changes
Relationship between at-home mSpirometry changes and changes in ACQ-6
Measured: Baseline Day 1 through Day 43 End of Study
Device Use Surveys
- Site clinical care team likelihood to recommend at-home mSpirometry
- Site clinical care team ease-of-use of at-home mSpirometry
- Site clinical care team device satisfaction
- Participant likelihood to recommend at-home mSpirometry
- Participant ease-of-use of at-home mSpirometry
- Participant device satisfaction
Measured: Baseline Day 1 through Day 43 End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start21 Apr 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate AsthmaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Long-Acting Beta Agonist
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koneksa Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757908
- Sponsor's protocol ID
- KH008
- Acronym
- LEARN
- Status last verified
- May 2024
- First submitted
- 24 Feb 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izmailova ES, Kilian R, Bakker JP, Evans S, Scotina AD, Reiss TF, Singh D, Wagner JA. Study protocol: A comparison of mobile and clinic-based spirometry for capturing the treatment effect in moderate asthma. Clin Transl Sci. 2023 Nov;16(11):2112-2122. doi: 10.1111/cts.13615. Epub 2023 Sep 8.
PubMed 37602889
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study in Moderate Asthma Participants Comparing the Treatment With Long-Acting Beta Agonist Between At-Home Mobile Spirometry and In-Clinic Spirometry (LEARN)
- ClinicalTrials.gov ID
- NCT05757908
- Acronym / sponsor ID
- LEARN / KH008
- Conditions
- Moderate Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Koneksa HealthIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 7 Mar 2023 (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.
The goal of this interventional study is to compare at-home mobile spirometry to in-clinic spirometry in participants with moderate asthma while taking a long-acting beta agonist (LABA).
The main questions it aims to answer are:
- Do at-home mobile spirometry and in-clinic spirometry assessments show a similar treatment effect (measured changes in FEV1) with the addition of LABA?
- Is at-home mobile spirometry as accurate as in-clinic spirometry in showing treatment effects (changes in FEV1)?
Participants will be asked to:
- Take standard of care LABA treatment once or twice a day
- Complete at-home mobile spirometry testing twice a day
- Complete asthma questionnaires twice a day
- Complete device use questionnaires
- Wear a wrist device (like a watch) to track physical activity and vital signs
- Visit the clinic for in-clinic spirometry testing once a week for 8 weeks
Detailed description
The study will recruit up to 60 participants with moderate uncontrolled asthma who are taking inhaled corticosteroids (ICS) at the time of study enrollment but will require LABA treatment as judged by their treating physician. The study will assess the LABA treatment effect in clinic and mobile spirometry, assess the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, patient reported outcome questionnaire. Additional objectives include an evaluation of patient and site-specific satisfaction with mobile spirometry technology.
The study consists of a one-week screening period, one-week baseline period, and up to 6-week interventional assessment period consisting of addition of LABA, for an estimated participant duration of 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Long-Acting Beta Agonist
| Arm | Type | Receives |
|---|---|---|
| Long-Acting Beta Agonist | Other | Drug: Long-Acting Beta AgonistStandard of care LABA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals 18 years or older
- Body mass index (BMI) 18 - 40 mg/m2 inclusive
- Participant with a diagnosis of moderate uncontrolled asthma
- Participant must be using a medium to high daily dose of inhaled corticosteroids (ICS) for a minimum of 6 weeks prior to screening
- Asthma that is not currently using long-acting beta-agonists (LABA) or log-acting muscarinic antagonist (LAMA) (ACQ score of 0.75 or higher) Note: A 2-week LABA/LAMA washout period is allowed prior to screening
Key exclusion criteria (10 listed)
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures or hospitalization (including ER visits) for the treatment of asthma within 3 months prior to screening, or have been hospitalized or have attended the ER for asthma more than twice in prior 6 months
- Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to Screening
- History of substance abuse in the last 6 months, excluding medical or recreational non- inhaled marijuana
- Currently taking other biologics to control asthma symptoms (allergy shots are acceptable)
- Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; or other lung diseases (e.g., emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease)
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 |
|---|---|---|
| Long-Acting Beta AgonistAlso: LABAThe Investigator will prescribe standard of care LABA to eligible study participants. Participants will self-administer LABA once or twice daily at the maximum feasible standard of care dosage, per the time points specified in the study Schedule of Assessments. LABA should be taken within 1 to 3 hours prior to morning and evening at-home mobile Spirometry testing. | Drug | Long-Acting Beta Agonist |
Primary outcome
Measured FEV1 Change to Treatment Effect
Time frame: Baseline Day 1 through Day 43 End of Study
Detection of treatment effect as measured by change from baseline in morning FEV1 measured in change over time for at-home mobile and in-clinic Spirometry
Measured FEV1 Change and Comparison of Variability
Time frame: Baseline Day 1 through Day 43 End of Study
Change from baseline and comparison of variability (measured via confidence interval) in morning FEV1 for at-home morning mSpirometry compared to morning in-clinic Spirometry
7 secondary outcomes
Mobile Spirometry Compliance
Time frame: Baseline Day 1 through Day 43 End of Study
Relationship Between In-clinic and Mobile Spirometry Parameters
Time frame: Baseline Day 1 through Day 43 End of Study
Diurnal Differences in Mobile Spirometry
Time frame: Baseline Day 1 through Day 43 End of Study
Time to Treatment Effect
Time frame: Baseline Day 1 through Day 43 End of Study
Treatment Effect
Time frame: Baseline Day 1 through Day 43 End of Study
Mobile Spirometry Changes
Time frame: Baseline Day 1 through Day 43 End of Study
Device Use Surveys
Time frame: Baseline Day 1 through Day 43 End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 37602889Izmailova ES, Kilian R, Bakker JP, Evans S, Scotina AD, Reiss TF, Singh D, Wagner JA. Study protocol: A comparison of mobile and clinic-based spirometry for capturing the treatment effect in moderate asthma. Clin Transl Sci. 2023 Nov;16(11):2112-2122. doi: 10.1111/cts.13615. Epub 2023 Sep 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-Acting Beta Agonist in people with Moderate Asthma, run by Koneksa Health at 9 sites in United States.
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 11 inclusion and 10 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured FEV1 Change to Treatment Effect (time frame: Baseline Day 1 through Day 43 End of Study). The study lists 2 primary outcomes in all. 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 NCT05757908, which also lists 1 linked publication.
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 3 May 2024.