Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01747629
First received: December 7, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.


Condition Intervention Phase
Asthma
Drug: Albuterol Spiromax® 90 mcg/inhalation
Drug: Placebo Spiromax
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week Comparison of the Efficacy and Safety and Steady-state Pharmacokinetics of Albuterol Spiromax® and Placebo in Subjects 12 Years

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Baseline adjusted FEV1 AUC 0-6 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This is a measure of the forced expiratory volume in 1 second at 30 minutes after each dose and serially over 6 hours following the last cumulative dose.


Secondary Outcome Measures:
  • Baseline-adjusted FEV1 AUC0-6 at Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This is a measure of the forced expiratory volume in 1 second at 30 minutes after each dose and serially over 6 hours following the last cumulative dose.

  • Baseline-adjusted FEV1 AUC0-6 at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    This is a measure of the forced expiratory volume in 1 second at 30 minutes after each dose and serially over 6 hours following the last cumulative dose.

  • Baseline-adjusted FEV1 AUC0-6 at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    This is a measure of the forced expiratory volume in 1 second at 30 minutes after each dose and serially over 6 hours following the last cumulative dose.


Other Outcome Measures:
  • Pharmacokinetic Measures [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of albuterol will be determined on Day 1 after the first dose administration and at steady-state.


Enrollment: 159
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol Spiromax® 90 mcg/inhalation
Administered as 2 inhalations four times a day for 12 weeks
Drug: Albuterol Spiromax® 90 mcg/inhalation
Orally inhaled dry powder
Placebo Comparator: Placebo Spiromax
Administered as 2 inhalations four times a day for 12 weeks
Drug: Placebo Spiromax
Orally inhaled dry powder - lactose

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent/assent
  • At least 12 years of age at screening
  • General good health
  • Persistent asthma, with an FEV1 50-80% predicted
  • Ability to perform spirometry in an acceptable manner as per protocol guidelines
  • Other inclusion criteria apply

Exclusion Criteria:

  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
  • 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
  • Hospitalization due to asthma exacerbation 2 or more times in the past year
  • Initiation of immunotherapy or dose escalation during the study period
  • Other exclusion criteria apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747629

  Show 35 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Clinical Project Leader Teva Respiratory R&D
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01747629     History of Changes
Other Study ID Numbers: ABS-AS-304
Study First Received: December 7, 2012
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Asthma
dry powder inhaler
short-acting beta2-agonist
SABA
bronchoconstriction
bronchodilation
bronchodilator
metered dose inhaler
Albuterol Spiromax®

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014