Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild… (NCT00442351) | Clinical Trial Compass
TerminatedPhase 4
Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Stopped: Slow Enrollment
26 participantsStarted 2006-09
Plain-language summary
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sign informed consent
* Be 18-75 years of age, of either sex and any race
* Have asthma for \>= 12 months
* Have mild or moderate persistent asthma
* Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period
* Be off treatment with leukotriene receptor antagonist (LTRA) for at least 14 days prior to Screening
* Have an FEV1 \>=65% but \<=85% of predicted normal value at Screening and at Baseline when SABAs have been withheld for at least 6 hours
* Demonstrate an increase of absolute FEV1 of \>= 12% with an absolute volume increase of at least 200mL during Screening. Written documentation of FEV1 reversibility of \>= 12% within 2 years prior to Screening was acceptable in lieu of testing. FEV1 reversibility testing should be done after withholding inhaled SABA for at least 6 hours
* Have a frequency of asthma score of at least 2 (at least 2 symptoms) and/or frequency of bronchodilator use score of at least 2 at Screening
* Have a Total Asthma Severity Score (TASS)…
What they're measuring
1
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.