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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 4

Conditions

Asthma

Treatments

Drug: Fluticasone/Salmeterol HFA

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

132 participants in 2 patient groups

Arm 1
Other group
Description:
Fluticasone/Salmeterol HFA MDI without counter
Treatment:
Drug: Fluticasone/Salmeterol HFA
Arm 2
Other group
Description:
Fluticasone/Salmeterol HFA MDI with counter
Treatment:
Drug: Fluticasone/Salmeterol HFA

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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