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A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo MDPI
Albuterol MDPI
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, dry powder inhaler, short-acting beta2-agonist, SABA, bronchoconstriction, bronchodilation, bronchodilator, metered dose inhaler

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent/assent
  • General good health
  • Persistent asthma, with an FEV1 50-80% predicted.
  • Ability to perform spirometry in an acceptable manner as per protocol guidelines.
  • Ability to perform PEFR with a handheld peak flow meter.
  • Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
  • Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
  • Non-smokers.
  • Capable of understanding the requirements, risks, and benefits of study participation.
  • Other inclusion criteria apply.

Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of severe milk protein allergy.
  • History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
  • Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
  • History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
  • Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
  • Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
  • Other exclusion criteria apply.

Sites / Locations

  • Teva Investigational Site 10077
  • Teva Investigational Site 10079
  • Teva Investigational Site 10569
  • Teva Investigational Site 10053
  • Teva Investigational Site 10065
  • Teva Investigational Site 10572
  • Teva Investigational Site 10075
  • Teva Investigational Site 10061
  • Teva Investigational Site 10066
  • Teva Investigational Site 10068
  • Teva Investigational Site 10069
  • Teva Investigational Site 10058
  • Teva Investigational Site 10060
  • Teva Investigational Site 10064
  • Teva Investigational Site 10071
  • Teva Investigational Site 10073
  • Teva Investigational Site 10070
  • Teva Investigational Site 10063
  • Teva Investigational Site 10571
  • Teva Investigational Site 10067
  • Teva Investigational Site 10072
  • Teva Investigational Site 10050
  • Teva Investigational Site 10057
  • Teva Investigational Site 10051
  • Teva Investigational Site 10078
  • Teva Investigational Site 10054
  • Teva Investigational Site 10568
  • Teva Investigational Site 10055
  • Teva Investigational Site 10056
  • Teva Investigational Site 10076
  • Teva Investigational Site 10684
  • Teva Investigational Site 10570
  • Teva Investigational Site 10049
  • Teva Investigational Site 10052
  • Teva Investigational Site 10685
  • Teva Investigational Site 10059
  • Teva Investigational Site 10074
  • Teva Investigational Site 10062

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo MDPI

Albuterol MDPI

Arm Description

Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.

Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.

Outcomes

Primary Outcome Measures

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

Secondary Outcome Measures

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Participants With Adverse Events
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol 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 the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat
Participants With Clinically Significant Vital Sign Assessments
For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min). Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant: Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute

Full Information

First Posted
August 25, 2011
Last Updated
May 28, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01424813
Brief Title
A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
Official Title
A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, dry powder inhaler, short-acting beta2-agonist, SABA, bronchoconstriction, bronchodilation, bronchodilator, metered dose inhaler

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo MDPI
Arm Type
Placebo Comparator
Arm Description
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Arm Title
Albuterol MDPI
Arm Type
Experimental
Arm Description
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo MDPI
Other Intervention Name(s)
Placebo Spiromax®
Intervention Description
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Albuterol MDPI
Other Intervention Name(s)
ProAir® RespiClick, Albuterol Spiromax®
Intervention Description
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Primary Outcome Measure Information:
Title
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Description
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Time Frame
Day 1, Day 8 and Day 85
Secondary Outcome Measure Information:
Title
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Description
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Time Frame
Day 1
Title
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Description
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Time Frame
Day 8
Title
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Description
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Time Frame
Day 85
Title
Participants With Adverse Events
Description
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol 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 the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame
Day 1 to Day 92
Title
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Description
Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat
Time Frame
Day 1 (Baseline), Day 85
Title
Participants With Clinically Significant Vital Sign Assessments
Description
For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min). Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant: Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute
Time Frame
Day 8, Day 85
Other Pre-specified Outcome Measures:
Title
Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Time Frame
Day 1, Day 8, Day 85
Title
Percent Change From Baseline in FEV1 AUC 0-6
Time Frame
Day 1
Title
Percent Change From Baseline in FEV1 AUC
Time Frame
Day 8
Title
Percent Change From Baseline in FEV1 AUC
Time Frame
Day 85
Title
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Time Frame
Day 1, Day 8, Day 85
Title
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
Time Frame
Day 1
Title
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Time Frame
Day 8
Title
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Time Frame
Day 85
Title
Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Time Frame
Day 1, Day 8, Day 85
Title
Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
Time Frame
Day 1, Day 8, Day 85
Title
Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
Time Frame
Day 1, Day 8, Day 85
Title
Duration of Response on Days 1, 8 and 85
Description
Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes
Time Frame
Day 1, Day 8, Day 85
Title
Percent of Symptom Free Days on the Patient Diary
Time Frame
Treatment days 1 through 85
Title
Percent of Rescue Medication Free Days in the Patient Diary
Time Frame
Treatment days 1 through 85
Title
Morning Peak Expiratory Flow Reading Reported on Patient Diary
Time Frame
Treatment days 1 through 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent/assent General good health Persistent asthma, with an FEV1 50-80% predicted. Ability to perform spirometry in an acceptable manner as per protocol guidelines. Ability to perform PEFR with a handheld peak flow meter. Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1. Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit. Non-smokers. Capable of understanding the requirements, risks, and benefits of study participation. Other inclusion criteria apply. Exclusion Criteria: Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV). A known hypersensitivity to albuterol or any of the excipients in the formulations. History of severe milk protein allergy. History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV). Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV). Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including. Other exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Leader
Organizational Affiliation
Teva Respiratory R&D
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 10077
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 10079
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 10569
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10053
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10065
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10572
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10075
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10061
City
Roseville
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10066
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10068
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10069
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10058
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10060
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10064
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10071
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10073
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Teva Investigational Site 10070
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Teva Investigational Site 10063
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10571
City
Gaithersburg
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10067
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10072
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10050
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Teva Investigational Site 10057
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10051
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10078
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10054
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10568
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10055
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10056
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10076
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10684
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10570
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10049
City
Live Oak
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10052
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10685
City
Waco
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10059
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10074
City
Puyallup
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 10062
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26369589
Citation
Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.
Results Reference
derived

Learn more about this trial

A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

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