A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 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:
NCT01058863
First received: January 27, 2010
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function. During the trial the participants will also be given a hydrofluoroalkane (HFA) , metered dose inhaler (MDI) of albuterol. These medications will be given to the participants at two different doses. Approximately 66 participants will be enrolled in the study following screening and a 14 day run-in period. Participants who qualify for the study will be selected randomly to receive all of the treatments, on separate occasions, including placebo on one of the treatment days, 3-7 days apart. There will be 5 visits where the medications are given. The total number of clinic visits are approximately 7 visits to the clinic.


Condition Intervention Phase
Asthma
Drug: Albuterol DPI 90mcg
Drug: Albuterol MDI 90mcg
Drug: Albuterol DPI 180mcg
Drug: Albuterol MDI 180mcg
Other: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax and ProAir® HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Baseline-adjusted forced expiratory volume at one second (FEV1) liters per hour (L*hr) area-under-the-curve (AUC0-6). Tthe baseline is the treatment day baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline-adjusted percent predicted FEV1percent per hour (%*hr) AUC0-6 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Spontaneous and elicited treatment emergent adverse events (AEs);physical exam; vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol DPI 90mcg
Albuterol 90mcg delivered with a DPI inhaler
Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo Comparator
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
Experimental: Albuterol DPI 180mcg
Albuterol 180 mcg delivered with a DPI inhaler
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo Comparator
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
Active Comparator: Albuterol MDI 90mcg
Albuterol 90 mcg delivered with a MDI inhaler
Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo Comparator
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
Active Comparator: Albuterol MDI 180mcg
Albuterol 180 mcg delivered with a MDI inhaler
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Other: Placebo Comparator
Three inhalers will contain placebo given as double-blind medication on one of 5 treatment days.
Placebo Comparator: Placebo Comparator Drug: Albuterol DPI 90mcg
Albuterol DPI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 90mcg
Albuterol MDI delivers 90mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol DPI 180mcg
Albuterol DPI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.
Drug: Albuterol MDI 180mcg
Albuterol MDI delivers 180mcg of Albuterol in the excipient lactose with each inhalation given as double-blind medication on one of 5 treatment days.

  Eligibility

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

Inclusion Criteria:

  • Must provide written informed consent,
  • Be between 12 years of age and older,
  • Male or Female, females of non-child bearing potential or using reliable contraception
  • Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180mcg albuterol
  • Stable low dose of Inhaled Corticosteroids
  • Non-smoker, 12 month free and 10-pack years history
  • Otherwise healthy
  • Other criteria apply

Exclusion Criteria:

  • Pregnant
  • Allergic to albuterol or severe milk protein allergy
  • Must not be on another trial for 30days.
  • Other 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: NCT01058863

Locations
United States, California
Teva Clinical Study Site
Huntington Beach, California, United States, 92647
Teva Clinical Study Site
Rolling Hills Est., California, United States, 90274
Teva Clinical Study Site
San Diego, California, United States, 92123
United States, Colorado
Teva Clinical Study Site
Colorado Springs, Colorado, United States, 080907
United States, Florida
Teva Clinical Study Site
Margate, Florida, United States, 33036
Teva Clinical Study Site
Miami, Florida, United States, 33173
United States, Missouri
Teva Clinical Study Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Teva Clinical Study Site
Skillman, New Jersey, United States, 08558
United States, North Carolina
Teva Clinical Study Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Teva Clinical Study Site
Cincinnati, Ohio, United States, 45231
Teva Clinical Study Site
Dayton, Ohio, United States, 45406
United States, Oregon
Teva Clinical Study Site
Medford, Oregon, United States, 97504
Teva Clinical Study Site
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Study Leader Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01058863     History of Changes
Other Study ID Numbers: ABS-AS-201
Study First Received: January 27, 2010
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014