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

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:

• 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

Study Overview

• Status: Completed
• Conditions: Moderate Asthma
• Intervention / Treatment: Drug: Long-Acting Beta Agonist

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Koneksa Health; Phone Number: 5518660025; Email: KH008@koneksahealth.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • AllerVie Research Clinic
  • Georgia
    • Columbus, Georgia, United States, 31904
      • AllerVie Research Clinic
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc.
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • The Asthma & Allergy Center, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Texas
    • El Paso, Texas, United States, 79902
      • El Paso Pulmonary Association
    • San Antonio, Texas, United States, 78229
      • South Texas Allergy & Asthma Medical Professionals Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals 18 years or older
2. Body mass index (BMI) 18 - 40 mg/m2 inclusive
3. Participant with a diagnosis of moderate uncontrolled asthma
4. Participant must be using a medium to high daily dose of inhaled corticosteroids (ICS) for a minimum of 6 weeks prior to screening
5. 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
6. Pre-bronchodilator FEV1 ≥ 60% and ≤100% of the predicted normal values at screening
7. 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.
8. Participant is judged to be in good health based on medical history, physical examination, and vital sign measurements
9. Non-smokers or ex-smokers (including vape or inhaled cannabis) who have stopped smoking more than 1 year ago
10. Women of childbearing potential must have a negative urine pregnancy test before enrolling at Baseline Day 1
11. 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:

1. 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
2. Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to Screening
3. History of substance abuse in the last 6 months, excluding medical or recreational non- inhaled marijuana
4. Currently taking other biologics to control asthma symptoms (allergy shots are acceptable)
5. 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)
6. Clinically unstable participants or history of non-compliance as assessed by the PI
7. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening
8. 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
9. Participants treated with oral or parenteral corticosteroids in the previous 4 weeks prior to screening
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Long-Acting Beta Agonist; Standard of care LABA

Drug: Long-Acting Beta Agonist; 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.; Other Names: LABA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline Day 1 through Day 43 End of Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobile Spirometry Compliance	Percentage of compliance for once and twice daily at-home mSpirometry	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	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	Baseline Day 1 through Day 43 End of Study
Treatment Effect	Treatment effect as measured by change from baseline in ACQ-6	Baseline Day 1 through Day 43 End of Study
Mobile Spirometry Changes	Relationship between at-home mSpirometry changes and changes in ACQ-6	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	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)	Baseline Day 1 through Day 43 End of Study

Collaborators and Investigators

• Sponsor: Koneksa Health

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: KH008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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