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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424813
• Other study ID #: ABS-AS-301
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2011
• Last updated: May 28, 2015
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß2-adrenergic receptor antagonists or non-selective ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo MDPI
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.
• Albuterol MDPI
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.

Locations

Country	Name	City	State
United States	Teva Investigational Site 10063	Bethesda	Maryland
United States	Teva Investigational Site 10077	Birmingham	Alabama
United States	Teva Investigational Site 10684	Charleston	South Carolina
United States	Teva Investigational Site 10051	Cincinnati	Ohio
United States	Teva Investigational Site 10569	Costa Mesa	California
United States	Teva Investigational Site 10068	Denver	Colorado
United States	Teva Investigational Site 10069	Denver	Colorado
United States	Teva Investigational Site 10059	Fairfax	Virginia
United States	Teva Investigational Site 10053	Fountain Valley	California
United States	Teva Investigational Site 10571	Gaithersburg	Maryland
United States	Teva Investigational Site 10065	Huntington Beach	California
United States	Teva Investigational Site 10572	Huntington Beach	California
United States	Teva Investigational Site 10049	Live Oak	Texas
United States	Teva Investigational Site 10075	Los Angeles	California
United States	Teva Investigational Site 10056	Medford	Oregon
United States	Teva Investigational Site 10076	Medford	Oregon
United States	Teva Investigational Site 10058	Miami	Florida
United States	Teva Investigational Site 10060	Miami	Florida
United States	Teva Investigational Site 10050	Missoula	Montana
United States	Teva Investigational Site 10054	Oklahoma City	Oklahoma
United States	Teva Investigational Site 10568	Oklahoma City	Oklahoma
United States	Teva Investigational Site 10064	Ormond Beach	Florida
United States	Teva Investigational Site 10070	Owensboro	Kentucky
United States	Teva Investigational Site 10079	Phoenix	Arizona
United States	Teva Investigational Site 10074	Puyallup	Washington
United States	Teva Investigational Site 10057	Raleigh	North Carolina
United States	Teva Investigational Site 10061	Roseville	California
United States	Teva Investigational Site 10052	San Antonio	Texas
United States	Teva Investigational Site 10066	San Diego	California
United States	Teva Investigational Site 10071	Savannah	Georgia
United States	Teva Investigational Site 10570	Spartanburg	South Carolina
United States	Teva Investigational Site 10072	St. Louis	Missouri
United States	Teva Investigational Site 10078	Sylvania	Ohio
United States	Teva Investigational Site 10062	Tacoma	Washington
United States	Teva Investigational Site 10055	Tulsa	Oklahoma
United States	Teva Investigational Site 10685	Waco	Texas
United States	Teva Investigational Site 10067	Wheaton	Maryland
United States	Teva Investigational Site 10073	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period		Day 1, Day 8, Day 85	No
Other	Percent Change From Baseline in FEV1 AUC 0-6		Day 1	No
Other	Percent Change From Baseline in FEV1 AUC		Day 8	No
Other	Percent Change From Baseline in FEV1 AUC		Day 85	No
Other	Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period		Day 1, Day 8, Day 85	No
Other	Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1		Day 1	No
Other	Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8		Day 8	No
Other	Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85		Day 85	No
Other	Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)		Day 1, Day 8, Day 85	No
Other	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		Day 1, Day 8, Day 85	No
Other	Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes		Day 1, Day 8, Day 85	No
Other	Duration of Response on Days 1, 8 and 85	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	Day 1, Day 8, Day 85	No
Other	Percent of Symptom Free Days on the Patient Diary		Treatment days 1 through 85	No
Other	Percent of Rescue Medication Free Days in the Patient Diary		Treatment days 1 through 85	No
Other	Morning Peak Expiratory Flow Reading Reported on Patient Diary		Treatment days 1 through 85	No
Primary	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.	Day 1, Day 8 and Day 85	No
Secondary	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.	Day 1	No
Secondary	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.	Day 8	No
Secondary	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.	Day 85	No
Secondary	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.	Day 1 to Day 92	Yes
Secondary	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	Day 1 (Baseline), Day 85	Yes
Secondary	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	Day 8, Day 85	Yes