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Home > Protocol Summaries: Compounds > salmeterol > Protocol Summary for 101182

Protocol Summary for 101182

Protocol Summary
Protocol Id: 101182
Secondary Ids:
  • TURBOHALER Faktor
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
Phase: Phase 4
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: interventional
Oversight Authority:
  • Germany: Federal Institute for Drugs and Medical Devices
Collaborators:
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
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: January 2004
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary Outcomes:
  • Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
Conditions:
  • Airway Obstruction
Keywords:
  • Asthma
  • Salmeterol
  • Formoterol
  • Airway resistance
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A N/A
Enrollment: 77
Enrollment Type:
Healthy Volunteers?: No
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information