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OpenTrials
Completed

NCT Number: NCT01302587

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

albuterol

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2011
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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