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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arformoterol | Experimental | beta-2 agonist bronchodilator |
|
| salmeterol | Active Comparator | beta-2 agonist bronchodilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arformoterol | Drug | 15 mcg administered via nebulizer |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication | FEV1 | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald A Mahler, M.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17898020 | Background | Janssens W, VandenBrande P, Hardeman E, De Langhe E, Philps T, Troosters T, Decramer M. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J. 2008 Jan;31(1):78-83. doi: 10.1183/09031936.00024807. Epub 2007 Sep 26. | |
| 23745526 | Derived | Mahler DA, Waterman LA, Ward J, Gifford AH. Comparison of dry powder versus nebulized beta-agonist in patients with COPD who have suboptimal peak inspiratory flow rate. J Aerosol Med Pulm Drug Deliv. 2014 Apr;27(2):103-9. doi: 10.1089/jamp.2013.1038. Epub 2013 Jun 8. |
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26 patients screened: 5 excluded because did not meet exclusion criteria; 1 excluded because of exacerbation after visit 1.
Recruitment dates: July 2011 to October 2012; Location: medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Arformoterol First, Then Salmeterol | Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention |
| FG001 | Salmeterol First, Then Arformoterol | Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Arformoterol first and Salmeterol first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication | FEV1 | Posted | Mean | Standard Deviation | mL | 2 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arformoterol | Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald A. Mahler, M.D. | Dartmouth-Hitchcock | 603 650-5533 | Donald.a.mahler@hitchcock.org |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| salmeterol | Drug | 50 mcg delivered vis Diskus |
|
|
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Salmeterol | Salmeterol dry powder (50 mcg) via Diskus | 0 | 20 | 0 | 20 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |