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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327353
First Posted: May 18, 2006
Last Update Posted: May 22, 2009
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.
Information provided by:
GlaxoSmithKline
  Purpose
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 Intervention Phase
Asthma Drug: formoterol (TURBOHALER) Drug: Salmeterol (DISKUS) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 77
Study Start Date: January 2004
Intervention Details:
    Drug: formoterol (TURBOHALER) Drug: Salmeterol (DISKUS)
    Other Name: formoterol (TURBOHALER)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00327353


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00327353     History of Changes
Other Study ID Numbers: 101182
TURBOHALER Faktor
First Submitted: May 16, 2006
First Posted: May 18, 2006
Last Update Posted: May 22, 2009
Last Verified: May 2009

Keywords provided by GlaxoSmithKline:
Asthma
Salmeterol
Formoterol
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