Asthma
Conditions
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 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).
Interventions
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
OTHERPlacebo for Asmanex twisthaler
Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements. | Twelve (12) weeks | The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asmanex Twisthaler Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks | 17 |
| Placebo Inhaler Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks | 9 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 6 | 5 |
| Overall Study | Did not meet protocol eligibility | 1 | 0 |
| Overall Study | Other | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Inhaler | Asmanex Twisthaler | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 17 Participants | 25 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 17 | 41.9 years STANDARD_DEVIATION 11.9 | 42.1 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 9 participants | 17 participants | 26 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 17 | 3 / 9 |
| serious Total, serious adverse events | 0 / 17 | 0 / 9 |
Outcome results
Primary
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Time frame: Twelve (12) weeks