Status:

COMPLETED

Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

Lead Sponsor:

SkyePharma AG

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.

Eligibility Criteria

Inclusion

  • Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion

  • Smoking history within the last 12 months
  • No history of respiratory tract infection within 4 weeks
  • No history or evidence of any clinically significant disease or abnormality

Key Trial Info

Start Date :

October 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2005

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT00830102

Start Date

October 1 2004

End Date

January 1 2005

Last Update

June 23 2011

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Investigational site

Belfast, Ireland

2

Investigational site

Derbyshire, United Kingdom

3

Investigational site

London, United Kingdom

4

Investigational site

Manchester, United Kingdom