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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01302587
First received: February 16, 2011
Last updated: June 21, 2012
Last verified: June 2012
  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:

Primary Outcome Measures:
  • The number of times the counter advanced but the inhaler did not actuate [ Time Frame: Days 1 through 46 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01302587     History of Changes
Other Study ID Numbers: ABM-AS-307
Study First Received: February 16, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
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 30, 2014