Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the investigators are looking at how much and for how long the two drugs can open up the small airways in the lungs. This will be done with breathing tests on all subjects, and with high resolution CT scans on subjects who agree to this optional part of the study. Half of subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take Serevent the first two weeks and Brovana the second two weeks. All subjects will also take Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms. After a Screening Visit to determine eligibility, subjects will be randomly assigned to receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include questionnaires, review of health and medications, and breathing tests before and after taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before and after taking the study drug at both test visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brovana (nebulized arformoterol) | Experimental | Brovana (nebulized arformoterol) treatment for 2 weeks |
|
| Serevent (Salmeterol dry powder inhaler) | Experimental | Serevent (Salmeterol dry powder inhaler) treatment for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized arformoterol | Drug | Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor. The nebulization time is ~9 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory capacity (absolute volume BTPS, L) | The inspiratory capacity (absolute volume BTPS, L) measured 3 times prior to treatment and 5-6 times after treatment will be contrasted between the two treatments (nebulized arformoterol and DPI salmeterol) using a mixed effects linear model. The model will include treatment order, albuterol response FEV1 in mL, time of day and whether the IC was from plethysmography and time of prior dose of study med (nominal 12 hours). | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory capacity (absolute change, % change, %predicted change) | Inspiratory capacity: evaluated as absolute change, % change, %predicted change. Considered at predose (trough) and AUC 75-195 minutes after dose | Week 4 |
| Inspiratory capacity (%ref TLC) |
Not provided
Inclusion Criteria:
Age >=40 years
History of smoking >=20 pack-years of cigarettes
Be using medically acceptable birth-control measures if a female of child-bearing potential
Be willing to withhold any existing short or long-acting bronchodilators for the appropriate time period prior to each test day. Use of inhaled corticosteroids is not exclusionary, but will be maintained at a constant level throughout the study.
Must be willing and able to perform spirometry, slow vital capacity, plethysmography, DLCO, and 6 minute walk after appropriate instruction.
Informed consent
At the screening visit:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Salmeterol | Drug | Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler |
|
|
Inspiratory capacity as percent of reference total lung capacity |
| Week 4 |
| Other breathing test outcomes | FEV1, FVC, isovolume FEF25-75% referenced to pre-albuterol FVC at screening visit, SVCexp (from spirometric and plethysmographic measures), FRC, RV, ERV, IRV, RV/TLC, TLC, IC/TLC | Week 4 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D000588 |
| Amines |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |