Clinical Trial: Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbut

Brief Summary:

  1. The primary objective of this study is:

    • To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

  2. The secondary objectives of this study are:

    • To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
    • To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks [ Time Frame: Baseline and Visit 6 ]

FEV1


Original Primary Outcome: Change in post-exercise FEV1 [ Time Frame: Day -6-2, day 21 and day 42 ]

Current Secondary Outcome:

  • Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks [ Time Frame: Baseline and 3 weeks ]
    FEV1
  • Bronchial Responsiveness to Mannitol [ Time Frame: Baseline and 6 weeks ]
    Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
  • Concentration of Exhaled Nitric Oxide [ Time Frame: 6 weeks ]
  • Use of as Needed Medication [ Time Frame: 6 weeks ]
    Mean number of as needed inhalations taken before exercise
  • Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) [ Time Frame: Baseline e and 6 weeks ]
    Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.
  • Diary Recording of Asthma Symptoms [ Time Frame: 6 weeks ]
    Asthma symptoms during days with exercise
  • Number of Participants With an Adverse Event During the Study [ Time Frame: 6 weeks ]


Original Secondary Outcome:

  • Change in bronchial responsiveness to mannitol [ Time Frame: Day 0 and day 42 ]
  • Change in NO in exhaled air [ Time Frame: Day -6-2, day 0, day 21, day 42, day 42 + 2-5 days ]
  • Use of as Needed Medication [ Time Frame: Day 0 - day 42 ]


Information By: AstraZeneca

Dates:
Date Received: September 30, 2009
Date Started: September 2009
Date Completion:
Last Updated: July 6, 2012
Last Verified: July 2012