A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
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| ClinicalTrials.gov Identifier: NCT02275481 |
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Recruitment Status :
Terminated
(lack of enrollment)
First Posted : October 27, 2014
Results First Posted : October 2, 2017
Last Update Posted : June 27, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: Arformoterol tartrate inhalation solution Drug: Tiotropium | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 66 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Comparative Effectiveness and Safety Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects |
| Actual Study Start Date : | November 2014 |
| Actual Primary Completion Date : | September 14, 2016 |
| Actual Study Completion Date : | September 14, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BROVANA
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
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Drug: Arformoterol tartrate inhalation solution
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
Other Name: BROVANA |
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Active Comparator: SPIRIVA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
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Drug: Tiotropium
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Other Name: SPIRIVA |
- Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment [ Time Frame: Up to 90 days ]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.
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
- Subject has had 1 or more exacerbations (excluding current exacerbation) within the previous year (exacerbation defined as: an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and /or sputum beyond day to day variability sufficient to warrant a change in management of COPD (eg, treated with antibiotics and/or systemic corticosteroids or requiring an emergency room visit or an overnight stay at a hospital), OR
- Subject has had oxygen therapy use within 3 months prior to study entry.
- Subject is a current or ex-smoker with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Subject is willing and able to attend study visits/telephone contacts and adhere to all study assessments/procedures.
- Subject is willing and able to provide written informed consent.
Exclusion Criteria:
- Subject has current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Subject has a primary diagnosis of asthma.
- Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- Subject has a history of urinary retention or bladder neck obstruction type symptoms.
- Subject has a history of narrow angle glaucoma.
- Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs, as assessed by the Investigator.
- Subject has a history of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
- Subject is participating in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
- Subject is a staff member of the clinical site or a relative of a clinical site staff member.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275481
Show 28 study locations
| Study Director: | Respiratory Medical Director, MD | Sunovion |
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT02275481 |
| Other Study ID Numbers: |
SEP091-402 |
| First Posted: | October 27, 2014 Key Record Dates |
| Results First Posted: | October 2, 2017 |
| Last Update Posted: | June 27, 2018 |
| Last Verified: | June 2018 |
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Chronic obstructive pulmonary disease COPD Emphysema Chronic bronchitis |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Tiotropium Bromide Formoterol Fumarate Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |