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
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).
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 →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.
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Exclusion Criteria
Screening or have a cumulative smoking history of 10 pack-years or greater
Drug: Asmanex twisthaler
Other: Placebo for Asmanex twisthaler
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Also known as: Mometasone furoate inhalation powder
Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
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
| Milestone | Asmanex Twisthaler | Placebo Inhaler |
|---|---|---|
| Started | 17 | 9 |
| Completed | 10 | 3 |
| Not completed | 7 | 6 |
| Withdrew: Administrative | 6 | 5 |
| Withdrew: Did not meet protocol eligibility | 1 | 0 |
| Withdrew: Other | 0 | 1 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asmanex Twisthaler | — | 0/17 (0%) | 5/17 (29.4%) |
| Placebo Inhaler | — | 0/9 (0%) | 3/9 (33.3%) |
| Event | Asmanex Twisthaler | Placebo Inhaler |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/17 | 2/9 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/17 | 1/9 |
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 0/17 | 1/9 |
| PyrexiaGeneral disorders | 1/17 | 0/9 |
| Acute sinusitisInfections and infestations | 1/17 | 0/9 |
| Oral candidiasisInfections and infestations | 1/17 | 0/9 |
| HeadacheNervous system disorders | 1/17 | 0/9 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 1/17 | 0/9 |
| Scar excisionSurgical and medical procedures | 1/17 | 0/9 |
| Age, Categorical(Participants) | Asmanex Twisthaler | Placebo Inhaler | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 8 | 25 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Asmanex Twisthaler | Placebo Inhaler | Total |
|---|---|---|---|
| Mean | 41.9 ± 11.9 | 42.6 ± 17.0 | 42.1 ± 13.5 |
| Sex: Female, Male(Participants) | Asmanex Twisthaler | Placebo Inhaler | Total |
|---|---|---|---|
| Female | 10 | 7 | 17 |
| Male | 7 | 2 | 9 |
| Region of Enrollment(participants) | Asmanex Twisthaler | Placebo Inhaler | Total |
|---|---|---|---|
| United States | 17 | 9 | 26 |
No study locations are listed for this record.
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mometasone Furoate