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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01424813
First received: August 25, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: Albuterol Spiromax®
Phase 2
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 of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The area under the curve (AUC 0-6) Baseline-adjusted forced expiratory volume in 1 second (FEV1) over the 12-week treatment period [ Time Frame: Day 1, Day 7 and Day 84 ] [ Designated as safety issue: No ]
    The weighted average over six hours of the FEV1 measures adjusted for the baseline measure recorded on days 1, 7 and 84 of the treatment period. FEV1 is the Force Expiratory volume over 1 second measured using a spirometry. AUC is the area under the curve.


Secondary Outcome Measures:
  • Baseline-adjusted FEV1 AUC 0-6 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Baseline-adjusted FEV1 AUC 0-6 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Baseline-adjusted FEV1 AUC 0-6 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Percent change from baseline in FEV1 AUC 0-6 over the 12-week treatment period [ Time Frame: Day 1, Day 7, Day 84 ] [ Designated as safety issue: No ]
  • Percent change from baseline in FEV1 AUC 0-6 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percent change from baseline in FEV1 AUC [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Percent change from baseline in FEV1 AUC [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Maximum percent change from baseline in FEV1 within 2 hours post dose over the 12-week treatment period [ Time Frame: Day 1, Day 7, Day 84 ] [ Designated as safety issue: No ]
  • Maximum percent change from baseline in FEV1 within 2 hours post dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum percent change from baseline in FEV1 within 2 hours post dose [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Time to onset of effect (change in FEV1 of 12% from baseline within 30 minutes postdose) [ Time Frame: Day 1, Day 7, Day 84 ] [ Designated as safety issue: No ]
  • 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 7, day 84 ] [ Designated as safety issue: No ]
  • 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 7, day 84 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Day 1, day 7, day 84 ] [ Designated as safety issue: No ]
    for those who responded within 30 minutes

  • Percent of symptom free days on the patient diary [ Time Frame: Treatment days 1 through 84 ] [ Designated as safety issue: No ]
  • Percent rescue medication free days on the patient diary [ Time Frame: Treatment days 1 through 84 ] [ Designated as safety issue: No ]
  • Morning peak expiratory flow reading reported on patient diary [ Time Frame: Treatment days 1 through 84 ] [ Designated as safety issue: No ]
  • Maximum percent change from baseline in FEV1 within 2 hours post dose [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 157
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®
This is an orally inhaled dry powder with a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks
Drug: Albuterol Spiromax®
This is an orally inhaled dry powder dosed at 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks
Placebo Comparator: Placebo
This is an orally inhaled dry powder with 0 micrograms per day of albuterol administered as 2 inhalations of 0 mcg /inhalation four times a day for 12 weeks
Drug: Placebo
This is an orally inhaled dry powder with 0 micrograms per day of albuterol administered as 2 inhalations of 0 mcg /inhalation four times a day for 12 weeks

  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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424813

  Show 38 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: NCT01424813     History of Changes
Other Study ID Numbers: ABS-AS-301
Study First Received: August 25, 2011
Last Updated: December 19, 2013
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

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 April 22, 2014