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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant COPD.
Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be enrolled; a total of 40 subjects is planned.
Subjects will all have background ipratropium-albuterol administered four times daily. Subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.
The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest CT scan gas trapping as an exploratory outcome.
The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ipratropium/albuterol | Active Comparator | 1 puff 4 times daily |
|
| Budesonide | Experimental | budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily |
|
| budesonide/formoterol | Experimental | budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) pre-bronchodilator | FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose budesonide and budesonide/formoterol | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status | Administer St. George's Respiratory Questionnaire at randomization and 12 weeks. | 12 weeks |
| Dyspnea | Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D Crapo, MD | National Jewish Health | Principal Investigator |
| Edwin K Silverman, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Barry J Make, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Medical Center | Birmingham | Alabama | 35294 | United States | ||
| Harbor UCLA Medical Center |
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| budesonide/formoterol | Drug | Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily |
|
|
| Ipratropium/albuterol | Drug | Inhaled ipratropium/albuterol combination 2 puffs four times daily |
|
|
| 12 weeks |
| Six minute walk distance | Evaluate six minute walk distance at randomization and 12 weeks | 12 weeks |
| Forced vital capacity (FVC) pre-bronchodilator | 12 weeks |
| Post-bronchodilator FEV1 | 12 weeks |
| Patient-reported exacerbations | 12 weeks |
| Patient reported adverse events | 12 weeks |
| Post-bronchodilator FVC | 12 weeks |
| CT scan gas trapping | Before and 12 weeks after randomization |
| Torrance |
| California |
| 90502 |
| United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Reliant Medical Group | Worcester | Massachusetts | 01608 | United States |
| Temple University Medical Center | Philadelphia | Pennsylvania | 19140 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D000068600 | Albuterol, Ipratropium Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D009241 | Ipratropium |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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