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Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist (LEARN)

Primary Purpose

Moderate Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long-Acting Beta Agonist
Sponsored by
Koneksa Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Moderate Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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.

Sites / Locations

  • AllerVie Research ClinicRecruiting
  • AllerVie Research ClinicRecruiting
  • Northeast Medical Research Associates, Inc.Recruiting
  • The Asthma & Allergy Center, PCRecruiting
  • American Health ResearchRecruiting
  • Clinical Research of Rock HillRecruiting
  • Spartanburg Medical ResearchRecruiting
  • El Paso Pulmonary AssociationRecruiting
  • South Texas Allergy & Asthma Medical Professionals ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Long-Acting Beta Agonist

Arm Description

Standard of care LABA

Outcomes

Primary Outcome Measures

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 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

Secondary Outcome Measures

Mobile Spirometry Compliance
Percentage of compliance for once and twice daily at-home mSpirometry
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)
Diurnal Differences in Mobile Spirometry
Diurnal differences in morning versus evening for at-home mSpirometry parameters, e.g., FEV1
Time to Treatment Effect
Time to treatment effect detection using at-home mSpirometry via change in FEV1
Treatment Effect
Treatment effect as measured by change from baseline in ACQ-6
Mobile Spirometry Changes
Relationship between at-home mSpirometry changes and changes in ACQ-6
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

Full Information

First Posted
February 24, 2023
Last Updated
August 3, 2023
Sponsor
Koneksa Health
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1. Study Identification

Unique Protocol Identification Number
NCT05757908
Brief Title
Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist
Acronym
LEARN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koneksa Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Long-Acting Beta Agonist
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-Acting Beta Agonist
Arm Type
Other
Arm Description
Standard of care LABA
Intervention Type
Drug
Intervention Name(s)
Long-Acting Beta Agonist
Other Intervention Name(s)
LABA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measured FEV1 Change to Treatment Effect
Description
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
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Measured FEV1 Change and Comparison of Variability
Description
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
Time Frame
Baseline Day 1 through Day 43 End of Study
Secondary Outcome Measure Information:
Title
Mobile Spirometry Compliance
Description
Percentage of compliance for once and twice daily at-home mSpirometry
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Relationship Between In-clinic and Mobile Spirometry Parameters
Description
Evaluate the relationship between in-clinic and mSpirometry FEV1 and other Spirometry parameters (e.g., FVC) Relationship between other Spirometry measurements (e.g., FVC)
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Diurnal Differences in Mobile Spirometry
Description
Diurnal differences in morning versus evening for at-home mSpirometry parameters, e.g., FEV1
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Time to Treatment Effect
Description
Time to treatment effect detection using at-home mSpirometry via change in FEV1
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Treatment Effect
Description
Treatment effect as measured by change from baseline in ACQ-6
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Mobile Spirometry Changes
Description
Relationship between at-home mSpirometry changes and changes in ACQ-6
Time Frame
Baseline Day 1 through Day 43 End of Study
Title
Device Use Surveys
Description
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
Time Frame
Baseline Day 1 through Day 43 End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koneksa Health
Phone
5518660025
Email
KH008@koneksahealth.com
Facility Information:
Facility Name
AllerVie Research Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hollie Russell
Phone
205-209-4187
Email
hrussell@allervie.com
First Name & Middle Initial & Last Name & Degree
Weily Soong, MD
Facility Name
AllerVie Research Clinic
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kushondra Shirah
Phone
706-324-4012
Ext
137
Email
kshirah@allervie.com
First Name & Middle Initial & Last Name & Degree
Robert Chrzanowski, MD
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Friedman
Phone
508-992-7595
Ext
5480
Email
cfriedman@nemra-us.com
First Name & Middle Initial & Last Name & Degree
S. David Miller, MD
Facility Name
The Asthma & Allergy Center, PC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Watson
Phone
402-592-2055
Email
dwatson@asthmaandallergycenter.com
First Name & Middle Initial & Last Name & Degree
Linda Ford, MD
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Divel
Phone
704-926-8041
Email
CDivel@ahres.com
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal, MD
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline B Reynolds
Phone
803-251-9502
Email
creynolds@cresrh.com
First Name & Middle Initial & Last Name & Degree
Michael Denenberg, MD
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Crockford
Email
ncrockford@medresearch.com
First Name & Middle Initial & Last Name & Degree
Charles Fogarty, MD
Facility Name
El Paso Pulmonary Association
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Abamukong
Phone
253-298-7143
Email
christian.abamukong@elligodirect.com
First Name & Middle Initial & Last Name & Degree
Carlo Hatem, MD
Facility Name
South Texas Allergy & Asthma Medical Professionals Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Villarreal
Phone
210-616-5385
Email
mario@staampresearch.com
First Name & Middle Initial & Last Name & Degree
Erika Gonzalez, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data that underlie results in a publication
IPD Sharing Time Frame
Upon preliminary analysis (if applicable) and end of study.
IPD Sharing Access Criteria
Publications will be shared with Clinical Site Investigators and industry professionals.

Learn more about this trial

Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist

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