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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices.
Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
All participants were provided an AirDuo® Digihaler™ and ProAirDuo® Digihaler™, which the participants could choose to use or not. This trial did not restrict participants from using other asthma treatments in addition to or in lieu of the Digihalers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirDuo and ProAir | Experimental | This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirDuo Digihaler | Combination Product | Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year. Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Daily Doses of ProAir® Digihaler™ | This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up. | up to 1 year |
| Mean Number of Daily Doses AirDuo® Digihaler™. | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up. | up to 1 year |
| Median Number of Daily Doses of ProAir® Digihaler™ | This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up. | up to 1 year |
| Median Number of Daily Doses of AirDuo® Digihaler™ | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenace Inhaler Adherence Rates | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (>80% of puffs), moderate (50-80% of puffs), and low levels (<50% of puffs) of adherence to maintenance inhalers over the course of the trial. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Exacerbations | up to 1 year | |
| Number of Hospitalizations | up to 1 year | |
| Number of Emergency Room Visits |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Njira Lugogo, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AirDuo and ProAir | This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™. AirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year. Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis. ProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AirDuo and ProAir | This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™. AirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year. Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis. ProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Daily Doses of ProAir® Digihaler™ | This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up. | Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™. | Posted | Mean | Standard Deviation | doses per day | up to 1 year |
|
Up to 1 year
Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not Using Either AirDuo or ProAir | Participants used neither inhaler during the course of the trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid 19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Njira Lugogo | University of Michigan | 734-647-6477 | nlugogo@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2024 | Dec 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| ProAir Digihaler | Combination Product | Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year. |
|
| Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics | All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors. | up to 1 year |
| Change in Mean Peak Inhalation Volume | Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs. | baseline to 1 year |
| Change in Mean Inspiratory Time | Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements. | baseline to 1 year |
| Change in Mean Peak Inspiratory Flow (PIF) | PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements. | baseline up to 1 year |
| Change in Mean Forced Expiratory Volume in One Second (FEV1) | FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements. | baseline up to 1 year |
| up to 1 year |
| Mean Asthma Control Test (ACT) Score | up to 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Mean Number of Daily Doses AirDuo® Digihaler™. | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up. | Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™. | Posted | Mean | Standard Deviation | doses per day | up to 1 year |
|
|
|
| Primary | Median Number of Daily Doses of ProAir® Digihaler™ | This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up. | Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™. | Posted | Median | Inter-Quartile Range | doses per day | up to 1 year |
|
|
|
| Primary | Median Number of Daily Doses of AirDuo® Digihaler™ | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up. | Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™. | Posted | Median | Inter-Quartile Range | doses per day | up to 1 year |
|
|
|
| Secondary | Maintenace Inhaler Adherence Rates | This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (>80% of puffs), moderate (50-80% of puffs), and low levels (<50% of puffs) of adherence to maintenance inhalers over the course of the trial. | Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™. | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| Secondary | Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics | All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors. | Because the outcome measure concerned response to biologics, all participants were included in this outcome, regardless of whether they chose to use either Digihaler or not. | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| Secondary | Change in Mean Peak Inhalation Volume | Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs. | Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller. | Posted | Mean | Standard Deviation | milliliters | baseline to 1 year |
|
|
|
|
| Secondary | Change in Mean Inspiratory Time | Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements. | Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller. | Posted | Mean | Standard Deviation | Seconds | baseline to 1 year |
|
|
|
|
| Secondary | Change in Mean Peak Inspiratory Flow (PIF) | PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements. | Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller. | Posted | Mean | Standard Deviation | Liters per minute | baseline up to 1 year |
|
|
|
|
| Secondary | Change in Mean Forced Expiratory Volume in One Second (FEV1) | FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements. | Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Home spirometry was not consistently used by all participants. | Posted | Mean | Standard Deviation | Liters | baseline up to 1 year |
|
|
|
| Other Pre-specified | Number of Exacerbations | Not Posted | up to 1 year | Participants |
| Other Pre-specified | Number of Hospitalizations | Not Posted | up to 1 year | Participants |
| Other Pre-specified | Number of Emergency Room Visits | Not Posted | up to 1 year | Participants |
| Other Pre-specified | Mean Asthma Control Test (ACT) Score | Not Posted | up to 1 year | Participants |
| 1 |
| 16 |
| 5 |
| 16 |
| 7 |
| 16 |
| EG001 | After Using AirDuo | Data reflects participants who experienced an AE within 1 month of using the AirDuo. | 0 | 84 | 0 | 84 | 7 | 84 |
| EG002 | After Using ProAir | Data reflects participants who experienced an AE within 1 month of using the ProAir. 73 participants used ProAir at all during the trial. | 0 | 73 | 2 | 73 | 1 | 73 |
| EG003 | After Using Both AirDuo and ProAir | Data reflects participants who experienced an AE within 1 month of using both AirDuo and ProAir inhalers together.73 participants used both AirDuo and ProAir during the trial. | 0 | 73 | 8 | 73 | 18 | 73 |
| Tremors & Generalized Weakness | General disorders | Systematic Assessment |
|
| Influenza A | Infections and infestations | Systematic Assessment |
|
| Covid 19 | Infections and infestations | Systematic Assessment |
|
| Adrenal Crisis | Endocrine disorders | Systematic Assessment |
|
| Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
|
| Graham Negative Rod Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Post-surgical low oxygen | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Baseline - ProAir |
|
|
| Follow Up/Exacerbation - ProAir |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.0020 |
| Other |
Test of paired differences |
|
| Baseline - ProAir |
|
|
| Follow Up/Exacerbation - ProAir |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.0003 |
| Other |
Test of paired differences |
|
| Baseline - ProAir |
|
|
| Follow Up/Exacerbation - ProAir |
|
|
| t-test, 2 sided |
Paired t-test |
| 0.0965 |
| Other |
Test of paired differences |