Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.
NCT ID: NCT05342558
Last Updated: 2022-04-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
133 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-19
Study Completion Date
2021-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a randomized, blinded, controlled clinical trial for mexican COPD patients.
Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype. BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners.
The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than FF/V in patients with the emphysema phenotype.
The general objective of the study is to determine the exacerbations outcome in patients with COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives include assessment of pulmonary function tests, quality of life, dyspnea and functional capacity change after a 24 weeks treatment.
Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype. BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners.
The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than FF/V in patients with the emphysema phenotype.
The general objective of the study is to determine the exacerbations outcome in patients with COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives include assessment of pulmonary function tests, quality of life, dyspnea and functional capacity change after a 24 weeks treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
NCT03858348
COPD
COPD Exacerbation
COMPLETED
A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01822899
Pulmonary Disease, Chronic Obstructive
COMPLETED
PHASE3
A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
NCT01342913
Pulmonary Disease, Chronic Obstructive
COMPLETED
PHASE3
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01817764
Pulmonary Disease, Chronic Obstructive
COMPLETED
PHASE3
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01879410
Pulmonary Disease, Chronic Obstructive
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Type and duration of the investigation: A randomized, blinded, controlled clinical trial; longitudinal, prospective, 3 years (Sep-2017 through Sep-2020).
Background: COPD associated to biomass smoke (BS-COPD) represents the third of all COPD cases in Latin America, and almost the 2% in general population prevalence studies. BS-COPD clinical spectrum is different to the one seen in COPD associated to tobacco smoke (TS-COPD). While BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype.
COPD-asthma phenotype in BS-COPD, probably explains that they have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners, because even though those patients are not included in traditional clinical trials, they are part of every day's practice.
In this sense, providing a specific treatment in this group of patients could change the disease progression, improving symptoms, quality of life, reducing costs, side effects and exacerbations. The investigators hypothesize that COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), may get a greater benefit by using a combination LABA/ICS (Fluticasone Furoate/Vilanterol - FF/V) therapy, whereas those with the emphysema phenotype with LABA/LAMA (Umeclidinium/Vilanterol U/V) therapy
The upside of these drugs is that both of them have the same easy-to-use device, and it is inhaled once a day only. Their efficacy and safety have been tested in TS\_COPD but not in BS-COPD. This trial will allow us to have a clinically and functionally characterization (using biological markers) of the BS-COPD phenotype and to compare those patients with those with the emphysema phenotype.
Hypothesis: Treatment with FF/V will be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; while U/V will be superior than FF/V in patients with the emphysema phenotype.
General objective: To determine the exacerbations outcome (exacerbations free interval, exacerbations frequency, severe exacerbations that needed hospitalization frequency, exacerbations frequency according to absolute and percentage (\>3%) blood eosinophils, exacerbations percentage for emphysema phenotype and COPD-asthma phenotype) in patients with COPD-asthma vs emphysema phenotype patients, treated with Fluticasone Furoate/Vilanterol 100/25 mcg/day vs Umeclidinium/Vilanterol 55/25 mcg/day, after 6 months of treatment.
Secondary objectives: To determine in both groups: (1) Pulmonary function change (FEV1, FVC and inspiratory capacity) (2) Impulse oscillometry resistance change (3) FeNO change (5) Quality of life change (CAT and Saint George) (6) Dyspnea change (mMRC, BDI y TDI) (7) Functional capacity change (6MWT distance). (8) To characterize and establish the frequency of the COPD-asthma phenotype in BS-COPD patients and emphysema-phenotype in TS-COPD patients.
Methods: Randomized double blind controlled clinical trial. Patients with at least one exacerbation in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid), and a smoking index \> 10 packs/year or a biomass smoke exposition index \> 100 hours/year. One hundred BS-COPD patients and one hundred TS-COPD patients will be included; both groups will be exposed to the two treatment options. Fifty patients from each group (BS-COPD and TS-COPD) will be assigned with FF/V and 50 from each group with U/V. Emphysema phenotype and air-trapping pattern will be determined with a CT image. All CTs will be assessed by a radiologist. Baseline DLco will also be correlated with the emphysema CT findings. Blood eosinophils, blood levels IgE, bronchodilator reversibility and baseline FeNO. Rate of exacerbations will be determined in both groups for a time period of 6 months. At the end of the study, the phenotype of each patient will be determined and treatment efficacy will be evaluated according to the phenotype. The sample size was chosen conventionally by considering that there are no other centers with a BS-COPD cohort. Treatment will be randomly assigned using a random numbers table. Safety evaluation includes severe adverse events (SAE) assessment (mainly pneumonia). During the informed consent signing visit (day -15), BS-COPD or TS-COPD diagnosis will be confirmed. There will be four in-clinic visits (baseline; +30 days; +90 days and +180 days) where the symptoms diary will be evaluated to determine the rate of exacerbations or other health resources use. Also, pulmonary function tests (spirometry pre and post-BD, IC) and functional capacity tests (6MWT) will be performed by each patient. Health related quality of life (SGRQ and CAT) and dyspnea (mMRC and BDI/TDI) questionnaires will also performed. There will be three telephonic visits (+60 days, +120 days, +210 days) where adverse events, concomitant medication, other health resources use and exacerbations since last visit will be assessed.
Background: COPD associated to biomass smoke (BS-COPD) represents the third of all COPD cases in Latin America, and almost the 2% in general population prevalence studies. BS-COPD clinical spectrum is different to the one seen in COPD associated to tobacco smoke (TS-COPD). While BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype.
COPD-asthma phenotype in BS-COPD, probably explains that they have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners, because even though those patients are not included in traditional clinical trials, they are part of every day's practice.
In this sense, providing a specific treatment in this group of patients could change the disease progression, improving symptoms, quality of life, reducing costs, side effects and exacerbations. The investigators hypothesize that COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), may get a greater benefit by using a combination LABA/ICS (Fluticasone Furoate/Vilanterol - FF/V) therapy, whereas those with the emphysema phenotype with LABA/LAMA (Umeclidinium/Vilanterol U/V) therapy
The upside of these drugs is that both of them have the same easy-to-use device, and it is inhaled once a day only. Their efficacy and safety have been tested in TS\_COPD but not in BS-COPD. This trial will allow us to have a clinically and functionally characterization (using biological markers) of the BS-COPD phenotype and to compare those patients with those with the emphysema phenotype.
Hypothesis: Treatment with FF/V will be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; while U/V will be superior than FF/V in patients with the emphysema phenotype.
General objective: To determine the exacerbations outcome (exacerbations free interval, exacerbations frequency, severe exacerbations that needed hospitalization frequency, exacerbations frequency according to absolute and percentage (\>3%) blood eosinophils, exacerbations percentage for emphysema phenotype and COPD-asthma phenotype) in patients with COPD-asthma vs emphysema phenotype patients, treated with Fluticasone Furoate/Vilanterol 100/25 mcg/day vs Umeclidinium/Vilanterol 55/25 mcg/day, after 6 months of treatment.
Secondary objectives: To determine in both groups: (1) Pulmonary function change (FEV1, FVC and inspiratory capacity) (2) Impulse oscillometry resistance change (3) FeNO change (5) Quality of life change (CAT and Saint George) (6) Dyspnea change (mMRC, BDI y TDI) (7) Functional capacity change (6MWT distance). (8) To characterize and establish the frequency of the COPD-asthma phenotype in BS-COPD patients and emphysema-phenotype in TS-COPD patients.
Methods: Randomized double blind controlled clinical trial. Patients with at least one exacerbation in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid), and a smoking index \> 10 packs/year or a biomass smoke exposition index \> 100 hours/year. One hundred BS-COPD patients and one hundred TS-COPD patients will be included; both groups will be exposed to the two treatment options. Fifty patients from each group (BS-COPD and TS-COPD) will be assigned with FF/V and 50 from each group with U/V. Emphysema phenotype and air-trapping pattern will be determined with a CT image. All CTs will be assessed by a radiologist. Baseline DLco will also be correlated with the emphysema CT findings. Blood eosinophils, blood levels IgE, bronchodilator reversibility and baseline FeNO. Rate of exacerbations will be determined in both groups for a time period of 6 months. At the end of the study, the phenotype of each patient will be determined and treatment efficacy will be evaluated according to the phenotype. The sample size was chosen conventionally by considering that there are no other centers with a BS-COPD cohort. Treatment will be randomly assigned using a random numbers table. Safety evaluation includes severe adverse events (SAE) assessment (mainly pneumonia). During the informed consent signing visit (day -15), BS-COPD or TS-COPD diagnosis will be confirmed. There will be four in-clinic visits (baseline; +30 days; +90 days and +180 days) where the symptoms diary will be evaluated to determine the rate of exacerbations or other health resources use. Also, pulmonary function tests (spirometry pre and post-BD, IC) and functional capacity tests (6MWT) will be performed by each patient. Health related quality of life (SGRQ and CAT) and dyspnea (mMRC and BDI/TDI) questionnaires will also performed. There will be three telephonic visits (+60 days, +120 days, +210 days) where adverse events, concomitant medication, other health resources use and exacerbations since last visit will be assessed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
COPD
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biomass Smoke COPD
Fluticasone Furoate/Vilanterol 100/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.
Umeclidinium/Vilanterol 62.5/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.
Group Type
ACTIVE_COMPARATOR
Fluticasone Furoate/Vilanterol 100/25 mcgs
Intervention Type
DRUG
Dry powder inhaler with 30 blisters. 100/25mcgs a day for 24 weeks.
Umeclidinium/Vilanterol 62.5/25 mcgs
Intervention Type
DRUG
Dry powder inhaler with 30 blisters. 62.5/25mcgs a day for 24 weeks
Tobacco Smoke COPD
Fluticasone Furoate/Vilanterol 100/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.
Umeclidinium/Vilanterol 62.5/25 mcgs. Dry powder inhaler with 30 blisters. 1 inhalation a day for 24 weeks.
Group Type
ACTIVE_COMPARATOR
Fluticasone Furoate/Vilanterol 100/25 mcgs
Intervention Type
DRUG
Dry powder inhaler with 30 blisters. 100/25mcgs a day for 24 weeks.
Umeclidinium/Vilanterol 62.5/25 mcgs
Intervention Type
DRUG
Dry powder inhaler with 30 blisters. 62.5/25mcgs a day for 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluticasone Furoate/Vilanterol 100/25 mcgs
Dry powder inhaler with 30 blisters. 100/25mcgs a day for 24 weeks.
Intervention Type
DRUG
Umeclidinium/Vilanterol 62.5/25 mcgs
Dry powder inhaler with 30 blisters. 62.5/25mcgs a day for 24 weeks
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Relvare
Anoro
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged 40 to 80 years
* Men and women (not fertile, not pregnant, or those with a effective birth control method)
* COPD diagnosis according to GOLD 2017 criteria with a FEV1 ≥ 30%
* Biomass smoke exposition index ≥ 100 hours/year or smoking index ≥ 10 packs/year,
* Patients with at least two exacerbations in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid)
* Patients with stable COPD (no exacerbations or respiratory infections in the 4 weeks prior inclusion).
* Men and women (not fertile, not pregnant, or those with a effective birth control method)
* COPD diagnosis according to GOLD 2017 criteria with a FEV1 ≥ 30%
* Biomass smoke exposition index ≥ 100 hours/year or smoking index ≥ 10 packs/year,
* Patients with at least two exacerbations in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid)
* Patients with stable COPD (no exacerbations or respiratory infections in the 4 weeks prior inclusion).
Exclusion Criteria
* Patients with allergies or intolerance to study medications
* Female patients on pregnancy, lactancy
* Patients with cancer diagnosis
* Patients with bronchiectasis, tuberculosis, recent COPD exacerbation, or any respiratory infection or cardiovascular anomaly that withholds the respiratory function test
* Female patients on pregnancy, lactancy
* Patients with cancer diagnosis
* Patients with bronchiectasis, tuberculosis, recent COPD exacerbation, or any respiratory infection or cardiovascular anomaly that withholds the respiratory function test
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Respiratory Diseases, Mexico
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alejandra Ramirez Venegas
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alejandra Ramírez-Venegas, M.S.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Enfermedades Respiratorias
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Respiratory Diseases 'Ismael Cosío Villegas'
Mexico City, Tlalpan, Mexico
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Mexico
References
Explore related publications, articles, or registry entries linked to this study.
Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
Reference Type
BACKGROUND
Camp PG, Ramirez-Venegas A, Sansores RH, Alva LF, McDougall JE, Sin DD, Pare PD, Muller NL, Silva CI, Rojas CE, Coxson HO. COPD phenotypes in biomass smoke- versus tobacco smoke-exposed Mexican women. Eur Respir J. 2014 Mar;43(3):725-34. doi: 10.1183/09031936.00206112. Epub 2013 Oct 10.
Reference Type
BACKGROUND
Lopez Varela MV, Muino A, Perez Padilla R, Jardim JR, Talamo C, Montes de Oca M, Valdivia G, Pertuze J, Halbert R, Menezes AM; PLATINO Group. [Treatment of chronic obstructive pulmonary disease in 5 Latin American cities: the PLATINO study]. Arch Bronconeumol. 2008 Feb;44(2):58-64. doi: 10.1016/s1579-2129(08)60016-6. Spanish.
Reference Type
BACKGROUND
Caballero A, Torres-Duque CA, Jaramillo C, Bolivar F, Sanabria F, Osorio P, Orduz C, Guevara DP, Maldonado D. Prevalence of COPD in five Colombian cities situated at low, medium, and high altitude (PREPOCOL study). Chest. 2008 Feb;133(2):343-9. doi: 10.1378/chest.07-1361. Epub 2007 Oct 20.
Reference Type
BACKGROUND
Ramirez-Venegas A, Sansores RH, Quintana-Carrillo RH, Velazquez-Uncal M, Hernandez-Zenteno RJ, Sanchez-Romero C, Velazquez-Montero A, Flores-Trujillo F. FEV1 decline in patients with chronic obstructive pulmonary disease associated with biomass exposure. Am J Respir Crit Care Med. 2014 Nov 1;190(9):996-1002. doi: 10.1164/rccm.201404-0720OC.
Reference Type
BACKGROUND
Bruce N, Perez-Padilla R, Albalak R. Indoor air pollution in developing countries: a major environmental and public health challenge. Bull World Health Organ. 2000;78(9):1078-92.
Reference Type
BACKGROUND
Regalado J, Perez-Padilla R, Sansores R, Paramo Ramirez JI, Brauer M, Pare P, Vedal S. The effect of biomass burning on respiratory symptoms and lung function in rural Mexican women. Am J Respir Crit Care Med. 2006 Oct 15;174(8):901-5. doi: 10.1164/rccm.200503-479OC. Epub 2006 Jun 23.
Reference Type
BACKGROUND
Moran-Mendoza O, Perez-Padilla JR, Salazar-Flores M, Vazquez-Alfaro F. Wood smoke-associated lung disease: a clinical, functional, radiological and pathological description. Int J Tuberc Lung Dis. 2008 Sep;12(9):1092-8.
Reference Type
BACKGROUND
Rivera RM, Cosio MG, Ghezzo H, Salazar M, Perez-Padilla R. Comparison of lung morphology in COPD secondary to cigarette and biomass smoke. Int J Tuberc Lung Dis. 2008 Aug;12(8):972-7.
Reference Type
BACKGROUND
Usmani OS, Barnes PJ. Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann Med. 2012 Mar;44(2):146-56. doi: 10.3109/07853890.2011.585656. Epub 2011 Jun 17.
Reference Type
BACKGROUND
Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603.
Reference Type
BACKGROUND
Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP; UPLIFT Study Investigators. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Nov 15;180(10):948-55. doi: 10.1164/rccm.200906-0876OC. Epub 2009 Sep 3.
Reference Type
BACKGROUND
Bujarski S, Parulekar AD, Sharafkhaneh A, Hanania NA. The asthma COPD overlap syndrome (ACOS). Curr Allergy Asthma Rep. 2015 Mar;15(3):509. doi: 10.1007/s11882-014-0509-6.
Reference Type
BACKGROUND
Brzostek D, Kokot M. Asthma-chronic obstructive pulmonary disease overlap syndrome in Poland. Findings of an epidemiological study. Postepy Dermatol Alergol. 2014 Dec;31(6):372-9. doi: 10.5114/pdia.2014.47120. Epub 2014 Dec 3.
Reference Type
BACKGROUND
Al-Kassimi FA, Alhamad EH, Al-Hajjaj MS, Raddaoui E, Alzeer AH, Alboukai AA, Somily AM, Cal JG, Ibrahim AF, Shaik SA. Can computed tomography and carbon monoxide transfer coefficient diagnose an asthma-like phenotype in COPD? Respirology. 2017 Feb;22(2):322-328. doi: 10.1111/resp.12902. Epub 2016 Sep 13.
Reference Type
BACKGROUND
Golpe R, Sanjuan Lopez P, Cano Jimenez E, Castro Anon O, Perez de Llano LA. Distribution of clinical phenotypes in patients with chronic obstructive pulmonary disease caused by biomass and tobacco smoke. Arch Bronconeumol. 2014 Aug;50(8):318-24. doi: 10.1016/j.arbres.2013.12.013. Epub 2014 Feb 25. English, Spanish.
Reference Type
BACKGROUND
Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.
Reference Type
BACKGROUND
Zach JA, Newell JD Jr, Schroeder J, Murphy JR, Curran-Everett D, Hoffman EA, Westgate PM, Han MK, Silverman EK, Crapo JD, Lynch DA; COPDGene Investigators. Quantitative computed tomography of the lungs and airways in healthy nonsmoking adults. Invest Radiol. 2012 Oct;47(10):596-602. doi: 10.1097/RLI.0b013e318262292e.
Reference Type
BACKGROUND
Miravitlles M, Calle M, Soler-Cataluna JJ. Clinical phenotypes of COPD: identification, definition and implications for guidelines. Arch Bronconeumol. 2012 Mar;48(3):86-98. doi: 10.1016/j.arbres.2011.10.007. Epub 2011 Dec 22. English, Spanish.
Reference Type
BACKGROUND
Cosio BG, Soriano JB, Lopez-Campos JL, Calle-Rubio M, Soler-Cataluna JJ, de-Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas P, Mir I, Peces-Barba G, Feu-Collado N, Solanes I, Alfageme I, Casanova C; CHAIN Study. Defining the Asthma-COPD Overlap Syndrome in a COPD Cohort. Chest. 2016 Jan;149(1):45-52. doi: 10.1378/chest.15-1055. Epub 2016 Jan 6.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C49-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310
COMPLETED
PHASE2
The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
NCT00559312
COMPLETED
NA
A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD
NCT01376245
COMPLETED
PHASE3
Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
NCT02164539
COMPLETED
PHASE2
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
NCT06474039
RECRUITING
PHASE3
Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2
NCT02119286
COMPLETED
PHASE3
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
NCT01313676
COMPLETED
PHASE3
Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
NCT01393145
WITHDRAWN
PHASE3
Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02729051
COMPLETED
PHASE3
Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01957163
COMPLETED
PHASE3
Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.
NCT01772147
COMPLETED
PHASE3
Chronic Obstructive Pulmonary Disease Endpoints Study
NCT00358358
COMPLETED
PHASE4
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
NCT00215436
COMPLETED
PHASE3
Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure
NCT04522596
RECRUITING
PHASE4
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
NCT03543176
COMPLETED
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
NCT06571942
RECRUITING
PHASE4
Study in Patients With COPD
NCT00215384
COMPLETED
PHASE2
Exhaled NO Based Treatment of Chronic Obstructive Pulmonary Disease (COPD), ICS/LABA Versus LAMA
NCT02546349
UNKNOWN
PHASE4
A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
NCT01551758
COMPLETED
PHASE3
Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
NCT02055352
COMPLETED
PHASE4