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Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

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ClinicalTrials.gov Identifier: NCT00658255
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 14, 2008
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
Average FEV1 during 12 hours [ Time Frame: Once a week for 5 weeks during treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00658255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
  • Urine levels of formoterol in 2 different formulations [ Time Frame: Once a week (12 hour urine collection) for 5 weeks during treatment period ]
  • Safety profiles of formoterol in 2 different formulations [ Time Frame: Once a week for 5 weeks during treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler
Official Title  ICMJE A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
Brief Summary The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stable Asthma
Intervention  ICMJE
  • Drug: budesonide/formoterol
    Other Name: Symbicort
  • Drug: formoterol
    Other Name: Oxis Turbuhaler
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: budesonide/formoterol
  • Active Comparator: 2
    Intervention: Drug: formoterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 8, 2008)
175
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658255
Other Study ID Numbers  ICMJE SD-039-0729
D5896C00729
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael E Ruff, MD Pharmaceutical Research & Consulting Inc
Study Chair: Catherine Bonuccelli AstraZeneca
PRS Account AstraZeneca
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP