Study Results
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
51 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-08-25
Study Completion Date
2016-08-12
Brief Summary
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A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.
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A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
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Detailed Description
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Patients with moderate/severe COPD are known to have static hyperinflation and to develop dynamic hyperinflation during exercise. Treatment with inhaled long-acting beta agonists and combination of the long-acting beta agonist (LABA), formoterol and the inhaled corticosteroid, budesonide has been shown to improve IC and decrease lung hyperinflation. In a similar previous pilot single centre study with budesonide/formoterol (Symbicort®) the analysis of cardiac outcomes demonstrated a decrease in maximum volume of oxygen (VO2) compared to placebo. Findings suggested that the use of Symbicort can decrease the cost of breathing and therefore reduce the cardiac demand experienced by COPD patients with hyperinflation at rest. The aim of this study is to investigate whether Symbicort therapy can decrease resting VO2 by decreasing static lung hyperinflation in subjects with COPD and to evaluate changes in cardiac function.
Conditions
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Chronic Obstructive Pulmonary Disease (COPD)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Symbicort pressurized Metered Dose Inhaler (pMDI)
Symbicort pressurized Metered Dose Inhaler (pMDI)
Group Type
ACTIVE_COMPARATOR
Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol
Intervention Type
DRUG
Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints
Placebo of reference drug
Placebo of reference drug
Group Type
PLACEBO_COMPARATOR
Matching Placebo pMDI 160/4.5 μg
Intervention Type
DRUG
Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.
Interventions
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Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol
Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints
Intervention Type
DRUG
Matching Placebo pMDI 160/4.5 μg
Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Signing of the informed consent form (ICF) prior to any study specific procedures, including withholding of medications.
2. Male or female, aged 40 to 80 years, inclusive, at Screening (Visit 1).
3. Has a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines with a post bronchodilator FEV1/FVC \<0.7 at Screening (Visit 1).
4. Has a post-bronchodilator FEV1 ≤65% of predicted value at Screening (Visit 1). National Health and Nutrition Examination Survey (NHANES) predicted normal standards will be used for all subjects.
5. Has an increase in IC of \>10% after the administration of 1 inhalation of open-label Symbicort pMDI administered with a spacer at Screening (Visit 1).
6. Has a cigarette smoking history of more than 10 pack-years (number of cigarettes smoked per day × number of years smoked)/20).
7. Be able to understand and comply with study requirements, as judged by the Investigator.
2. Male or female, aged 40 to 80 years, inclusive, at Screening (Visit 1).
3. Has a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines with a post bronchodilator FEV1/FVC \<0.7 at Screening (Visit 1).
4. Has a post-bronchodilator FEV1 ≤65% of predicted value at Screening (Visit 1). National Health and Nutrition Examination Survey (NHANES) predicted normal standards will be used for all subjects.
5. Has an increase in IC of \>10% after the administration of 1 inhalation of open-label Symbicort pMDI administered with a spacer at Screening (Visit 1).
6. Has a cigarette smoking history of more than 10 pack-years (number of cigarettes smoked per day × number of years smoked)/20).
7. Be able to understand and comply with study requirements, as judged by the Investigator.
Exclusion Criteria
1. Subject is an employee or relative of an employee involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
2. Previous enrollment or randomization in this study.
3. Participation in another clinical study with an investigational product (IP) during the last 30 days prior to Screening (Visit 1).
4. Subjects who are unable to discontinue their regular chronic COPD medications (including LAMAs and/or LABA/ICS) and/or who are unable or unwilling to comply with study requirements.
5. Subjects who are taking uLABAs (indacaterol, vilanterol) or uLABA-containing products.
6. Subjects who are taking PDE-4 inhibitors (roflumilast).
7. Subjects who are taking oral corticosteroids on a chronic, regular basis.
8. Subjects using daytime oxygen therapy.
9. Subjects who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
10. History of respiratory tract infection (including the upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to Screening (Visit 1).
11. Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or history of lung transplantation, or, in the Investigator's opinion, the subject may need thoracotomy or other lung surgery during the study.
12. History or current diagnosis of asthma and/or alpha 1 anti-trypsin deficiency.
13. Known active tuberculosis.
14. History of interstitial lung or massive pulmonary thromboembolic disease.
15. History of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener's syndrome, etc).
16. Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results of the study, or may affect the subject's ability to participate in the study.
17. Recent (within 12 months prior to Screening \[Visit 1\]) history of myocardial infarction, recent history of heart failure (New York Heart Association \[NYHA\] class III and IV, pulmonary edema, and/or cardiac arrhythmia.
18. Previous or current history of lung cancer.
19. History of cancer (within 5 years prior to Visit 1), except for non-metastatic, non melanoma skin cancer.
20. Subjects who cannot perform spirometry manuevers or tolerate body plethysmography.
21. Subjects with known hypersensitivity to Symbicort, its monocomponents (budesonide or formoterol), or its excipients.
2. Previous enrollment or randomization in this study.
3. Participation in another clinical study with an investigational product (IP) during the last 30 days prior to Screening (Visit 1).
4. Subjects who are unable to discontinue their regular chronic COPD medications (including LAMAs and/or LABA/ICS) and/or who are unable or unwilling to comply with study requirements.
5. Subjects who are taking uLABAs (indacaterol, vilanterol) or uLABA-containing products.
6. Subjects who are taking PDE-4 inhibitors (roflumilast).
7. Subjects who are taking oral corticosteroids on a chronic, regular basis.
8. Subjects using daytime oxygen therapy.
9. Subjects who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
10. History of respiratory tract infection (including the upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to Screening (Visit 1).
11. Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or history of lung transplantation, or, in the Investigator's opinion, the subject may need thoracotomy or other lung surgery during the study.
12. History or current diagnosis of asthma and/or alpha 1 anti-trypsin deficiency.
13. Known active tuberculosis.
14. History of interstitial lung or massive pulmonary thromboembolic disease.
15. History of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener's syndrome, etc).
16. Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results of the study, or may affect the subject's ability to participate in the study.
17. Recent (within 12 months prior to Screening \[Visit 1\]) history of myocardial infarction, recent history of heart failure (New York Heart Association \[NYHA\] class III and IV, pulmonary edema, and/or cardiac arrhythmia.
18. Previous or current history of lung cancer.
19. History of cancer (within 5 years prior to Visit 1), except for non-metastatic, non melanoma skin cancer.
20. Subjects who cannot perform spirometry manuevers or tolerate body plethysmography.
21. Subjects with known hypersensitivity to Symbicort, its monocomponents (budesonide or formoterol), or its excipients.
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AstraZeneca
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Research Site
Hartford, Connecticut, United States
Site Status
Research Site
Boston, Massachusetts, United States
Site Status
Research Site
Charlotte, North Carolina, United States
Site Status
Research Site
Philadelphia, Pennsylvania, United States
Site Status
Research Site
Spartanburg, South Carolina, United States
Site Status
Countries
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United States
References
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Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005 Mar;127(3):809-17. doi: 10.1378/chest.127.3.809.
Reference Type
RESULT
Casanova C, Cote C, de Torres JP, Aguirre-Jaime A, Marin JM, Pinto-Plata V, Celli BR. Inspiratory-to-total lung capacity ratio predicts mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Mar 15;171(6):591-7. doi: 10.1164/rccm.200407-867OC. Epub 2004 Dec 10.
Reference Type
RESULT
Diaz O, Villafranca C, Ghezzo H, Borzone G, Leiva A, Milic-Emili J, Lisboa C. Breathing pattern and gas exchange at peak exercise in COPD patients with and without tidal flow limitation at rest. Eur Respir J. 2001 Jun;17(6):1120-7. doi: 10.1183/09031936.01.00057801.
Reference Type
RESULT
Di Marco F, Milic-Emili J, Boveri B, Carlucci P, Santus P, Casanova F, Cazzola M, Centanni S. Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD. Eur Respir J. 2003 Jan;21(1):86-94. doi: 10.1183/09031936.03.00020102.
Reference Type
RESULT
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Reference Type
RESULT
O'Donnell DE, Lam M, Webb KA. Measurement of symptoms, lung hyperinflation, and endurance during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1557-65. doi: 10.1164/ajrccm.158.5.9804004.
Reference Type
RESULT
O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542-9. doi: 10.1164/ajrccm.160.2.9901038.
Reference Type
RESULT
O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
Reference Type
RESULT
O'Donnell DE, D'Arsigny C, Fitzpatrick M, Webb KA. Exercise hypercapnia in advanced chronic obstructive pulmonary disease: the role of lung hyperinflation. Am J Respir Crit Care Med. 2002 Sep 1;166(5):663-8. doi: 10.1164/rccm.2201003.
Reference Type
RESULT
Seibold H, Roth U, Lippert R, Kohler J, Wieshammer S, Henze E, Stauch M. Left heart function in chronic obstructive lung disease. Klin Wochenschr. 1986 May 2;64(9):433-41. doi: 10.1007/BF01727529.
Reference Type
RESULT
Sexton WL, Poole DC. Effects of emphysema on diaphragm blood flow during exercise. J Appl Physiol (1985). 1998 Mar;84(3):971-9. doi: 10.1152/jappl.1998.84.3.971.
Reference Type
RESULT
Sinderby C, Spahija J, Beck J, Kaminski D, Yan S, Comtois N, Sliwinski P. Diaphragm activation during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Jun;163(7):1637-41. doi: 10.1164/ajrccm.163.7.2007033.
Reference Type
RESULT
Stewart RI, Lewis CM. Cardiac output during exercise in patients with COPD. Chest. 1986 Feb;89(2):199-205. doi: 10.1378/chest.89.2.199.
Reference Type
RESULT
Synn A, Pinto-Plata V, Perham C, Celli B, Divo M. Improvement in cost of breathing after use of budesonide/formoterol in COPD patients with static hyperinflation. Presented at The American Thoracic Society International Conference, May 16-21, 2014.
Reference Type
RESULT
Vassaux C, Torre-Bouscoulet L, Zeineldine S, Cortopassi F, Paz-Diaz H, Celli BR, Pinto-Plata VM. Effects of hyperinflation on the oxygen pulse as a marker of cardiac performance in COPD. Eur Respir J. 2008 Nov;32(5):1275-82. doi: 10.1183/09031936.00151707. Epub 2008 Jun 11.
Reference Type
RESULT
Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
Reference Type
RESULT
Yan S, Kaminski D, Sliwinski P. Reliability of inspiratory capacity for estimating end-expiratory lung volume changes during exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Jul;156(1):55-9. doi: 10.1164/ajrccm.156.1.9608113.
Reference Type
RESULT
Divo MJ, DePietro MR, Horton JR, Maguire CA, Celli BR. Metabolic and cardiorespiratory effects of decreasing lung hyperinflation with budesonide/formoterol in COPD: a randomized, double-crossover, placebo-controlled, multicenter trial. Respir Res. 2020 Jan 20;21(1):26. doi: 10.1186/s12931-020-1288-3.
Reference Type
DERIVED
Other Identifiers
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D589CC00014
Identifier Type: -
Identifier Source: org_study_id
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