Clinical trial NCT05757908: Study Comparing At-Home Mobile Spirometry to In-Clinic in Moderate Asthma Participants Taking Long-Acting Beta Agonist
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
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Asthma
Keywords: Asthma
Lead sponsor: Koneksa Health
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Long-Acting Beta Agonist
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measured FEV1 Change to Treatment Effect
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Measured FEV1 Change and Comparison of Variability
timeFrame: Baseline Day 1 through Day 43 End of Study
Secondary outcomes:
measure: Mobile Spirometry Compliance
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Relationship Between In-clinic and Mobile Spirometry Parameters
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Diurnal Differences in Mobile Spirometry
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Time to Treatment Effect
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Treatment Effect
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Mobile Spirometry Changes
timeFrame: Baseline Day 1 through Day 43 End of Study
measure: Device Use Surveys
timeFrame: Baseline Day 1 through Day 43 End of Study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Research Clinic
state: Alabama
city: Columbus
country: United States
facility: AllerVie Research Clinic
state: Georgia
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Bellevue
country: United States
facility: The Asthma & Allergy Center, PC
state: Nebraska
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: El Paso
country: United States
facility: El Paso Pulmonary Association
state: Texas
city: San Antonio
country: United States
facility: South Texas Allergy & Asthma Medical Professionals Research
state: Texas
Study officials:
References:
citation: 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.