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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00327353
First received: May 16, 2006
Last updated: May 21, 2009
Last verified: May 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Names:
    • formoterol (TURBOHALER)
    • Salmeterol (DISKUS)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00327353     History of Changes
Other Study ID Numbers: 101182, TURBOHALER Faktor
Study First Received: May 16, 2006
Last Updated: May 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Asthma
Salmeterol
Formoterol
Airway resistance

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014