Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol

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. Identifier: NCT00327353
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 22, 2009
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Brief Summary:
Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices

Condition or disease Intervention/treatment Phase
Asthma Drug: formoterol (TURBOHALER) Drug: Salmeterol (DISKUS) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects
Study Start Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Drug: formoterol (TURBOHALER)
  • Drug: Salmeterol (DISKUS)
    Other Name: formoterol (TURBOHALER)

Primary Outcome Measures :
  1. Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication

Secondary Outcome Measures :
  1. Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal

Exclusion criteria:

  • Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks

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 identifier (NCT number): NCT00327353

GSK Investigational Site
Gauting, Bayern, Germany, 82131
GSK Investigational Site
Berlin, Germany, 14057
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00327353     History of Changes
Other Study ID Numbers: 101182
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 22, 2009
Last Verified: May 2009

Keywords provided by GlaxoSmithKline:
Airway resistance

Additional relevant MeSH terms:
Formoterol Fumarate
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action