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A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302587
First Posted: February 24, 2011
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
  Purpose
This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.

Condition Intervention
Asthma Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis Drug: Albuterol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:
  • The number of times the counter advanced but the inhaler did not actuate [ Time Frame: Days 1 through 46 ]
    MDI actuates but the counter display does not advance.


Secondary Outcome Measures:
  • The number of times the inhaler actuated but the counter did not advance. [ Time Frame: Days 1 through 46 ]
    Counter advances but the MDI does not actuate.


Enrollment: 306
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Albuterol MDI
All participants in this study will receive an albuterol MDI inhaler.
Drug: Albuterol
Albuterol MDI with integrated dose counter. Each participant will use 2 oral inhalations of 90 micrograms each of albuterol twice a day for the length of the study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
Criteria

Inclusion Criteria:

  • Written informed consent/assent
  • General good health
  • Asthma or COPD
  • Capable of understanding the requirements, risks, and benefits of study participation.
  • Able to demonstrate proper metered-dose inhaler use and technique.
  • Other inclusion criteria apply

Exclusion Criteria:

  • History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
  • Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
  • Is being treated with a long-acting β2-agonist alone.
  • Is currently being treated with Ventolin HFA.
  • Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
  • Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
  • Uncontrolled hypertension
  • History of any adverse reaction to any component of the HFA-MDI formulation.
  • Participation in any investigational drug study within the 30 days preceding the Screening Visit.
  • Other exclusion criteria apply.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302587


  Show 25 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Clinical Project Leader Teva Respiratory R&D
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT01302587     History of Changes
Other Study ID Numbers: ABM-AS-307
First Submitted: February 16, 2011
First Posted: February 24, 2011
Last Update Posted: June 22, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action