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OpenTrials
Completed

NCT Number: NCT00404261

Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).

The purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA MDI without counter.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Chronic Disease Disease Attributes Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Auchenflower, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatient
  • Documented physician diagnosis of asthma or COPD
  • Requires use of a controller and long acting beta 2 agonist
  • Ability to provided written informed consent

Exclusion criteria

  • Patients with life threatening asthma or COPD
  • Historical or current evidence of significant diseases
  • Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation
  • History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD
  • Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.

Treatment and study plan

Fluticasone/Salmeterol HFA

Drug

Fluticasone/Salmeterol HFA, 2 puffs twice daily

Primary outcomes

  1. Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).

    Time frame: Day 30

Secondary outcomes

  1. Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.

    Time frame: Day 30

  2. Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Label, Multicentre Study to Evaluate Patient Satisfaction With Fluticasone/Salmeterol HFA MDI With Counter in Adult Subjects (18 Years of Age and Older) With Asthma or COPD.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 28, 2006
Registry last updated
Oct 18, 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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