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TerminatedNCT00442351Updated Feb 9, 2022Results posted

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

A Phase 4 interventional study of Asmanex twisthaler and Placebo for Asmanex twisthaler in Asthma, sponsored by Organon and Co. Terminated. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

Why this study was terminated
Slow Enrollment
Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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).

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Conditions studied

  • Asthma

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03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 26 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Asmanex Twisthaler

    Drug: Asmanex twisthaler

  • Placebo comparator
    Placebo inhaler

    Other: Placebo for Asmanex twisthaler

Interventions

  • Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks

    Also known as: Mometasone furoate inhalation powder

  • OtherPlacebo for Asmanex twisthaler

    Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks

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What researchers measure

Primary outcomes

  1. 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

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Results

Posted Apr 16, 2010
Limitations and caveats
This study was terminated early due to a high screening failure rate and poor enrollment that resulted from stringent inclusion and exclusion criteria. Efficacy data were not evaluated.

Participant flow

Participant flow — Overall Study
MilestoneAsmanex TwisthalerPlacebo Inhaler
Started179
Completed103
Not completed76
Withdrew: Administrative65
Withdrew: Did not meet protocol eligibility10
Withdrew: Other01

Outcome measures

PrimaryChange 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

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Asmanex Twisthaler—0/17 (0%)5/17 (29.4%)
Placebo Inhaler—0/9 (0%)3/9 (33.3%)
Most frequent other events
Most frequent other events
EventAsmanex TwisthalerPlacebo Inhaler
Upper respiratory tract infectionInfections and infestations1/172/9
AsthmaRespiratory, thoracic and mediastinal disorders0/171/9
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders0/171/9
PyrexiaGeneral disorders1/170/9
Acute sinusitisInfections and infestations1/170/9
Oral candidiasisInfections and infestations1/170/9
HeadacheNervous system disorders1/170/9
Rhinitis allergicRespiratory, thoracic and mediastinal disorders1/170/9
Scar excisionSurgical and medical procedures1/170/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Asmanex TwisthalerPlacebo InhalerTotal
<=18 years000
Between 18 and 65 years17825
>=65 years011
Age, Continuous
Age, Continuous(years)Asmanex TwisthalerPlacebo InhalerTotal
Mean41.9 ± 11.942.6 ± 17.042.1 ± 13.5
Sex: Female, Male
Sex: Female, Male(Participants)Asmanex TwisthalerPlacebo InhalerTotal
Female10717
Male729
Region of Enrollment
Region of Enrollment(participants)Asmanex TwisthalerPlacebo InhalerTotal
United States17926
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00442351
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Mar 1, 2007
Start date
Sep 2006
Primary completion
Apr 2007
Completion
Apr 2007
Results posted
Apr 16, 2010
Last update
Feb 9, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mometasone Furoate

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