A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

This study has been terminated.
(Change to study required.)
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01218009
First received: October 7, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: albuterol dry-powder inhaler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center 52-Week Study to Assess the Safety of an Albuterol Dry-powder Inhaler in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Number of serious and unexpected adverse events [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Number of changes from Screening in the results of the physical examination that are clinically significant in the opinion of the investigator [ Time Frame: Week 12, Week 52 ] [ Designated as safety issue: Yes ]
  • Number of changes from Screening in the results of the laboratory evaluations that are clinically significant in the opinion of the investigator [ Time Frame: Week 12 and Week 52 ] [ Designated as safety issue: Yes ]
  • Number of changes from Screening in the results of the electrocardiograms (ECGs) that are clinically significant in the opinion of the investigator [ Time Frame: Week 12 and Week 52 ] [ Designated as safety issue: Yes ]
  • Number of changes from Screening in the vital signs that are clinically significant in the opinion of the investigator [ Time Frame: Week 12 and Week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 331
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albuterol dry-powder inhaler
There is a run in period after which, if the participants qualify, they will be randomized into one of two arms for 12 weeks. The arms are either placebo (no medication) or albuterol dry-powder inhaler. After that, all participants will all receive the active medication (albuterol dry-powder inhaler) for an additional 40 weeks.
Drug: albuterol dry-powder inhaler
This is an orally inhaled dry powder. Each inhalation delivers 90 micrograms (mcg). During the double-blind period, participants will use the inhaler four times each day at defined times.
Placebo Comparator: Placebo
There is a run in period after which, if the participants qualify, they will be randomized into one of two arms for 12 weeks. The arms are either placebo (no medication) or albuterol dry-powder inhaler. After that, all participants will all receive the active medication (albuterol dry-powder inhaler) for an additional 40 weeks.
Drug: Placebo
This intervention consists of a placebo dry-powder inhaler, one that contains no active medication. During the double-blind period, participants will use the inhalation four times each day at defined times.

  Eligibility

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

Inclusion Criteria:

  • Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening.
  • Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration
  • General good health
  • Capable of understanding the requirements, risks, and benefits of study participation
  • Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years
  • Other criteria apply

Exclusion Criteria:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit
  • Participation in any investigational drug trial within 30 days preceding the screening visit
  • 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 (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.
  • Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications
  • Inability to tolerate or unwillingness to comply with the protocol requirements.
  • History of life-threatening asthma
  • Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids
  • History of life-threatening asthma
  • Other criteria apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218009

  Show 30 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: NCT01218009     History of Changes
Other Study ID Numbers: ABS-AS-306
Study First Received: October 7, 2010
Last Updated: August 27, 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