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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00830102
• Date of registration: 26/01/2009
• Prospective Registration: No
• Primary sponsor: SkyePharma AG
• Public title: Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
• Scientific title: A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10µg and 250/10µg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250µg) and Formoterol (12µg) Concurrently or Alone in Patients With Asthma
• Date of first enrolment: October 2004
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00830102
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Ireland, United Kingdom

Contacts

• Name: SKP
• Affiliation: SkyePharma AG

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: fluticasone propionate, formoterol fumarate

Primary Outcome(s)

Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline [Time Frame: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose]

Secondary Outcome(s)

Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs [Time Frame: 10 weeks including pre- and post-study assessments]

Secondary ID(s)

SKY2028-2-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors