A Phase 4 interventional study of Arformoterol tartrate inhalation solution and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Sumitomo Pharma America, Inc.. Terminated at 28 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Sumitomo Pharma America, Inc. · Phase 4, Interventional, and Treatment
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg once daily (QD), each given for 90 days.
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital following a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor. Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Study medications will be dispensed to the subject at Visit 1. The objective of the study is to determine the comparative effectiveness of arformoterol and tiotropium on re-hospitalization and to assess safety in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 66 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female subjects ≥ 55 years-old are eligible for study participation if they have a physician-assessed diagnosis of COPD, have been discharged from the hospital due to a COPD exacerbation, and at least 1 of the following:
Exclusion Criteria:
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Drug: Arformoterol tartrate inhalation solution
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Drug: Tiotropium
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Also known as: BROVANA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Also known as: SPIRIVA
Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.
Time frame: Up to 90 days
Before recruitment and enrollment, each prospective subject was given a full explanation of the study, allowed to read the approved informed consent form and was provided ample time and the opportunity to ask any questions that may have arose.
| Milestone | BROVANA | SPIRIVA |
|---|---|---|
| Started | 32 | 34 |
| Completed | 23 | 31 |
| Not completed | 9 | 3 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: All other reasons combined | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.
No measurements were reported for this outcome.
Collected over The AE reporting period lasts ~ 19 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BROVANA | 2/32 (6.3%) | 15/32 (46.9%) | 19/32 (59.4%) |
| SPIRIVA | 1/34 (2.9%) | 13/34 (38.2%) | 23/34 (67.6%) |
| Event | BROVANA | SPIRIVA |
|---|---|---|
| chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 10/32 | 10/34 |
| pneumoniaInfections and infestations | 6/32 | 0/34 |
| respiratory failureRespiratory, thoracic and mediastinal disorders | 3/32 | 2/34 |
| abdominal painGastrointestinal disorders | 0/32 | 2/34 |
| hypoglycaemiaMetabolism and nutrition disorders | 0/32 | 2/34 |
| atrial fibrillationCardiac disorders | 1/32 | 0/34 |
| cardiac failureCardiac disorders | 1/32 | 0/34 |
| supraventricular tachycardiaCardiac disorders | 1/32 | 0/34 |
| acute sinusitisInfections and infestations | 1/32 | 0/34 |
| clostridium difficile colitisInfections and infestations | 1/32 | 0/34 |
| Event | BROVANA | SPIRIVA |
|---|---|---|
| chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 9/32 | 8/34 |
| dyspnoeaRespiratory, thoracic and mediastinal disorders | 1/32 | 6/34 |
| consitpationGastrointestinal disorders | 1/32 | 4/34 |
| hyperglycaemiaMetabolism and nutrition disorders | 2/32 | 4/34 |
| wheezingRespiratory, thoracic and mediastinal disorders | 0/32 | 4/34 |
| diarrhoeaGastrointestinal disorders | 3/32 | 1/34 |
| fatigueGeneral disorders | 0/32 | 3/34 |
| contusionInjury, poisoning and procedural complications | 0/32 | 3/34 |
| fallInjury, poisoning and procedural complications | 1/32 | 3/34 |
| headacheNervous system disorders | 2/32 | 3/34 |
full analysis set
| Age, Categorical(Participants) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 5 | 7 |
| >=65 years | 30 | 29 | 59 |
| Age, Continuous(years) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| Mean | 71.9 ± 6.86 | 72.1 ± 6.65 | 72.0 ± 6.70 |
| Sex: Female, Male(Participants) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| Female | 18 | 16 | 34 |
| Male | 14 | 18 | 32 |
| Ethnicity (NIH/OMB)(Participants) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 32 | 34 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 13 |
| White | 26 | 27 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | BROVANA | SPIRIVA | Total |
|---|---|---|---|
| United States | 32 | 34 | 66 |
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.