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

NCT05757908 | Completed

• 1 other identifier: KH008
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

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

Conditions

Moderate Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Mobile Spirometry Compliance

  Baseline Day 1 through Day 43 End of Study

• Relationship Between In-clinic and Mobile Spirometry Parameters

  Baseline Day 1 through Day 43 End of Study

• Diurnal Differences in Mobile Spirometry

  Baseline Day 1 through Day 43 End of Study

• Time to Treatment Effect

  Baseline Day 1 through Day 43 End of Study

• Treatment Effect

  Baseline Day 1 through Day 43 End of Study

Study Arms (1)

Long-Acting Beta Agonist

OTHER

Standard of care LABA

Drug: Long-Acting Beta Agonist

Interventions

Long-Acting Beta Agonist DRUG

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.

Also known as: LABA

Long-Acting Beta Agonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koneksa Health: lead

Study Sites (9)

AllerVie Research Clinic

Birmingham, Alabama, 35209, United States

Location

AllerVie Research Clinic

Columbus, Georgia, 31904, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

The Asthma & Allergy Center, PC

Bellevue, Nebraska, 68123, United States

Location

American Health Research

Charlotte, North Carolina, 28277, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

El Paso Pulmonary Association

El Paso, Texas, 79902, United States

Location

South Texas Allergy & Asthma Medical Professionals Research

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 37602889 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Long-Acting Beta Agonist

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: April 21, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)