AsthmaPhase 3NCT02969408

A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma

A Phase 3 study testing Albuterol Sulfate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Albuterol Sulfate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 397 participants
Where: 44 sitesUnited States
Study dates: 13 Feb 2017to 2 Feb 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The participant has had at least 1 episode of a severe CAE over the past 12 months before screening. If on a biologic (for example, omalizumab, mepolizumab, or reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these interventions.
The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at least 440 mcg daily of fluticasone propionate.
The participant's baseline asthma therapy regimen, including oral corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA), long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab, is allowed.
The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device.
The participant is willing to discontinue all other rescue or maintenance short-acting beta 2 agonist (SABA) or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.
Women of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (IMP).
Additional criteria apply, please contact the investigator for more information

Who cannot join

The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.
The participant has any other confounding underlying lung disorder other than asthma.
The participant has used an investigational drug within 5 half-lives of it being discontinued or 1 month of baseline visit, whichever is longer.
The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.
The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion.
The participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis.
Additional criteria apply, please contact the investigator for more information

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Teva Investigational Site 13959
Bakersfield, California, 93301
Teva Investigational Site 13937
Bangor, Maine, 04401
Teva Investigational Site 13947
Bellevue, Nebraska, 68123-4303
Teva Investigational Site 13962
Boerne, Texas, 78006
Teva Investigational Site 13960
Brick, New Jersey, 08724
Teva Investigational Site 13933
Centennial, Colorado, 80112
Teva Investigational Site 13929
Charleston, South Carolina, 29407
Teva Investigational Site 13953
Cincinnati, Ohio, 45231
Teva Investigational Site 13946
Clearwater, Florida, 33765
Teva Investigational Site 13920
Dallas, Texas, 75231
Teva Investigational Site 13949
East Providence, Rhode Island, 02914
Teva Investigational Site 13928
Edmond, Oklahoma, 73034
Teva Investigational Site 13956
Fairfax, Virginia, 22030
Teva Investigational Site 13958
Fort Mitchell, Kentucky, 41017
Teva Investigational Site 13941
Greenville, South Carolina, 29607
Teva Investigational Site 13951
Greenville, South Carolina, 29615
Teva Investigational Site 13936
High Point, North Carolina, 27262
Teva Investigational Site 13930
Houston, Texas, 77099
Teva Investigational Site 13924
Knoxville, Tennessee, 37909
Teva Investigational Site 13964
Litchfield Park, Arizona, 85340
Teva Investigational Site 13954
Los Angeles, California, 90048
Teva Investigational Site 13921
Loxahatchee Groves, Florida, 33470
Teva Investigational Site 13942
Miami, Florida, 33176
Teva Investigational Site 13927
Miami, Florida, 33186
Teva Investigational Site 13943
Michigan City, Indiana, 46360
Teva Investigational Site 13919
Missoula, Montana, 59808
Teva Investigational Site 13955
Oklahoma City, Oklahoma, 73131
Teva Investigational Site 13923
Orange, California, 92868
Teva Investigational Site 13948
Orlando, Florida, 32803
Teva Investigational Site 13934
Orlando, Florida, 32819
Teva Investigational Site 13931
Ormond Beach, Florida, 32174
Teva Investigational Site 13925
Overland Park, Kansas, 66210
Teva Investigational Site 13940
Owensboro, Kentucky, 42301
Teva Investigational Site 13932
Piscataway, New Jersey, 08854
Teva Investigational Site 13961
Riverside, California, 92506
Teva Investigational Site 13945
Rochester, New York, 14618
Teva Investigational Site 13939
San Antonio, Texas, 78230
Teva Investigational Site 13957
San Antonio, Texas, 78251
Teva Investigational Site 13926
Sarasota, Florida, 34239
Teva Investigational Site 13963
Savannah, Georgia, 31406
Teva Investigational Site 13952
South Burlington, Vermont, 05403
Teva Investigational Site 13938
Spartanburg, South Carolina, 29303
Teva Investigational Site 13965
St Louis, Missouri, 63141
Teva Investigational Site 13922
Verona, New Jersey, 07044

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About this study

Official title: A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (18 Years of Age or Older) With Asthma

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.

Conditions: Asthma
Being tested: Albuterol Sulfate
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albuterol SulfateDrug
Albuterol sulfate will be administered as per the dose and schedule specified in the arm.

Study groups in NCT02969408
Study group	Role	What they receive
ABS eMDPI	Experimental	Participants will receive 90 mcg of ABS via an eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. Receives: Drug: Albuterol Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
CAE was an occurrence of either severe CAE or moderate CAE. Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 milligrams (mg) prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization.
Moderate CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days, or an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization associated with an increase in asthma therapy that did not qualify for severe CAE as defined above.
Measured: Baseline (Day 1) to Week 12
Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Total number of inhalations taken in 1 day (that is, the 24-hour period on the day prior to the date of the CAE symptom peak) and at 3, 5, 7, 10, 14, and 21 days preceding the date of the severe CAE symptom peak were reported.
Measured: Baseline to Week 12
Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of days prior to the peak of a severe CAE when albuterol use first increased to greater than (>) 4, >12, and >20 inhalations was reported. Participants were counted in more than 1 category (that is, all of the >20 inhalation participants were also counted in the >12 category, and in the >4 category).
Measured: Baseline to Week 12
Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of albuterol inhalations used in the 24 hours preceeding a severe CAE is reported.
Measured: Baseline to Week 12

Secondary outcomes (1)

Number of Participants With Adverse Events (AEs)
AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Measured: Baseline up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20172 Feb 2018

First posted21 Nov 2016 (estimated)
Study start13 Feb 2017
Primary completion2 Feb 2018
Study completion2 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 397 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02969408
Sponsor's protocol ID: ABS-AS-30064
Status last verified: Nov 2021
First submitted: 17 Nov 2016
Last updated: 9 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (18 Years of Age or Older) With Asthma
ClinicalTrials.gov ID: NCT02969408
Acronym / sponsor ID: ABS-AS-30064
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 397 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 13 Feb 2017 (actual)
Primary completion: 2 Feb 2018 (actual)
Study completion: 2 Feb 2018 (actual)
First posted: 21 Nov 2016 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABS eMDPI	Experimental	Drug: Albuterol SulfateParticipants will receive 90 mcg of ABS via an eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The participant has had at least 1 episode of a severe CAE over the past 12 months before screening. If on a biologic (for example, omalizumab, mepolizumab, or reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these interventions.
The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at least 440 mcg daily of fluticasone propionate.
The participant's baseline asthma therapy regimen, including oral corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA), long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab, is allowed.
The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device.
The participant is willing to discontinue all other rescue or maintenance short-acting beta 2 agonist (SABA) or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.

Key exclusion criteria (7 listed)

The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.
The participant has any other confounding underlying lung disorder other than asthma.
The participant has used an investigational drug within 5 half-lives of it being discontinued or 1 month of baseline visit, whichever is longer.
The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.
The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albuterol SulfateAlbuterol sulfate will be administered as per the dose and schedule specified in the arm.	Drug	ABS eMDPI

Primary outcome

Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE
Time frame: Baseline (Day 1) to Week 12
CAE was an occurrence of either severe CAE or moderate CAE. Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 milligrams (mg) prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Moderate CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days, or an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization associated with an increase in asthma therapy that did not qualify for severe CAE as defined above.
Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE
Time frame: Baseline to Week 12
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Total number of inhalations taken in 1 day (that is, the 24-hour period on the day prior to the date of the CAE symptom peak) and at 3, 5, 7, 10, 14, and 21 days preceding the date of the severe CAE symptom peak were reported.
Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased
Time frame: Baseline to Week 12
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of days prior to the peak of a severe CAE when albuterol use first increased to greater than (>) 4, >12, and >20 inhalations was reported. Participants were counted in more than 1 category (that is, all of the >20 inhalation participants were also counted in the >12 category, and in the >4 category).
Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE
Time frame: Baseline to Week 12
Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of albuterol inhalations used in the 24 hours preceeding a severe CAE is reported.

1 secondary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to week 12

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABS eMDPI	397	381

Primary outcome: Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE

Time frame: Baseline (Day 1) to Week 12. Number. Unit: percentage of participants

Measure	ABS eMDPI n = 397
Value	17

Population analysed: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.

Primary outcome: Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: inhalations

Measure	ABS eMDPI n = 37
Day 1 prior to CAE	5.9 (7.95)
Day 3 prior to CAE	6.1 (9.93)
Day 5 prior to CAE	3.6 (2.89)
Day 7 prior to CAE	4.0 (2.61)
Day 10 prior to CAE	4.5 (4.24)
Day 14 prior to CAE	3.2 (1.87)
Day 21 prior to CAE	4.0 (3.06)

Population analysed: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants experiencing at least 1 severe CAE. Here, 'number analyzed' signifies participants who reported albuterol use in specified time interval.

Primary outcome: Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: days

Measure	ABS eMDPI n = 37
Albuterol use >4 inhalations	39.3 (26.79)
Albuterol use >12 inhalations	40.3 (26.95)
Albuterol use >20 inhalations	34.0 (30.84)

Population analysed: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed'= number of participants experiencing at least 1 severe CAE. 'Number analyzed'= participants who had any single day prior to CAE where their albuterol use exceeded 4, 12, or 20 inhalations in that day.

Primary outcome: Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: inhalations

Measure	ABS eMDPI n = 31
Value	5.9 (7.95)

Population analysed: ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants who experienced at least 1 severe CAE and reported albuterol use in the 24 hours preceding a severe CAE.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Week 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABS eMDPI	6 of 397 (1.5%)	68 of 397 (17.1%)	0 of 397

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albuterol Sulfate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE (time frame: Baseline (Day 1) to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.