Status:
TERMINATED
Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 P...
Eligibility Criteria
Inclusion
- 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) of at least 4 on 8 or more of the AM and PM recordings from the last 7 days during the Run-in period prior to Baseline and the AM of the Baseline Visit
- At Screening Visit, have sleep disturbance and scores of \>=2 on the interference with sleep rating scale (recall over the past 7 nights), and at least 30 on the Medical Outcomes Study Sleep scale (MOS-SS) Sleep Disturbance Sleep Scale (recall over the past 7 days)
- At the Baseline Visit, must have sleep disturbance and scores of \>= 2 on interference with sleep rating scale (recorded in a diary during the past 7 nights), and at least 30 on the MOS-SS Sleep Problems Index II 9 items(SLP 9)
- Exclusion Criteria
- Women who are pregnant or intend to become pregnant during the study
- Women who are nursing or intend to nurse during the study or within 30 days after completion
- Have participated in any clinical trial within the last 30 days or in one involving antibodies for asthma or rhinitis within 3 months prior to Screening
- Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month prior to Screening
- Have been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Screening
- Have used \>12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist per day on 2 consecutive days within 4 weeks prior to Screening
- Required more than 2 courses of oral/systemic corticosteroids for asthma within 12 months prior to Screening
- Have a history of sleep disorders, including narcolepsy, or use of medications that affect alertness or sleep
- Have sleep apnea, obstructive sleep apnea-hypopnea, or are being treated with the ventilation devices Continuous Positive Airway Pressure (CPAP) or (Bi-level Positive Airway Pressure (Bi-PAP), or are receiving oxygen by inhalation
- Are smokers or ex-smokers who have smoked within 6 months prior to
- Screening or have a cumulative smoking history of 10 pack-years or greater
- Are allergic to corticosteroids, SABAs, or LABAs
- Required ventilator support for respiratory failure secondary to asthma in the last 10 years
- Have a Body-Mass-Index greater than 35
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00442351
Start Date
September 1 2006
End Date
April 1 2007
Last Update
February 9 2022
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