Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)

Organon

Status and phase

Terminated

Phase 4

Conditions

Asthma

Treatments

Other: Placebo for Asmanex twisthaler

Drug: Asmanex twisthaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT00442351

P04654

IND Number: 46216 ( SCH 032088;Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

26 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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