Pulmonary Disease, Chronic Obstructive Clinical Trial
— SACOPDOfficial title:
COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
NCT number | NCT01253473 |
Other study ID # | SYMB0012 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | January 2016 |
Verified date | January 2021 |
Source | National Jewish Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | January 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. COPD GOLD Stage 2 and 3 (post-bronchodilator FEV1 35-80% predicted and FEV1/FVC <0.7 at the time of enrollment in COPDGene) by spirometry. 2. Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema) 3. Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease). 4. No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid. 5. Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed). Exclusion Criteria: 1. Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks. 2. Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications. 3. Symptomatic, untreated benign prostate hypertrophy. 4. Allergy to peanuts. 5. Glaucoma |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Birmingham Medical Center | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | National Jewish Health | Denver | Colorado |
United States | University of Iowa | Iowa City | Iowa |
United States | Temple University Medical Center | Philadelphia | Pennsylvania |
United States | Harbor UCLA Medical Center | Torrance | California |
United States | Reliant Medical Group | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Health Status | Administer St. George's Respiratory Questionnaire at randomization and 12 weeks. | 12 weeks | |
Secondary | Dyspnea | Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12. | 12 weeks | |
Secondary | Six minute walk distance | Evaluate six minute walk distance at randomization and 12 weeks | 12 weeks | |
Secondary | Forced vital capacity (FVC) pre-bronchodilator | 12 weeks | ||
Secondary | Post-bronchodilator FEV1 | 12 weeks | ||
Secondary | Patient-reported exacerbations | 12 weeks | ||
Secondary | Patient reported adverse events | 12 weeks | ||
Secondary | Post-bronchodilator FVC | 12 weeks | ||
Secondary | CT scan gas trapping | Before and 12 weeks after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|