Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention
NCT ID: NCT05764993
Last Updated: 2023-06-15
Study Results
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.
RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-06-01
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
T Lymphocyte Cells in Individuals Experiencing an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT00281229
Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
NCT00281216
Changes in Cytokine Levels During an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT00281242
Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
NCT00368446
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
NCT05214508
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Group #1: SCIgR with Cuvitru 125 mg/kg/week + standard of care management = 20 patients
Group #2: Standard of care management = 20 patients
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group #1
SCIgR with Cuvitru 125 mg/kg/week + standard of care management
CUVITRU - Ig subcutaneous human 20%
Subcutaneous Immunoglobin Replacement Therapy, SCigR
Standard Medical Therapy
Standard Medical Therapy
Group #2
Standard of care management = 20 patients
Standard Medical Therapy
Standard Medical Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CUVITRU - Ig subcutaneous human 20%
Subcutaneous Immunoglobin Replacement Therapy, SCigR
Standard Medical Therapy
Standard Medical Therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient that meet three (3) or more of the five (5) following criteria.
1. Dyspnea ≥ 5 on a visual analog scale
2. Respiratory rate ≥ 24 breaths per minute
3. Heart rate ≥ 95 beats per minute
4. Resting SaO2 \< 92% breathing ambient air of the patient's usual oxygen prescription and/or change in saturation \> 3% from baseline
5. CRP ≥ 10 mg/L
3. Established diagnosis of COPD with PFTs showing FEV1/FVC \< 70% or FEV1/VC ratio below the 5th percentile of the predicted value.\[14\]
4. Subjects must have adherence with triple therapy \[Inhaled Corticosteroid (ICS), Long-acting beta2-adrenergic agonist (LABA), Long-acting muscarinic antagonist (LAMA)\] for greater than 90 Days prior to consideration of participation in this study.
5. With triple therapy onboard, the subject must have ≥ 2 steroid-requiring exacerbations (defined by increased respiratory symptoms of increased cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids within the past 12 months OR one exacerbation requiring inpatient hospitalization
6. Medically stable with no acute hospitalizations for non-COPD related events within the last 3 months
7. Expected life expectancy \> 1 year
8. Stable Cardiovascular Disease, with no planned intervention
9. No history of pulmonary embolism or embolic event
10. Hepatic function \< Class B Child-Pugh criteria
11. Renal insufficiency with eGFR \> 60 mL/min/1.73m2
12. No history of DVT or thrombotic events
13. No history of prior organ transplant
14. Female subjects of childbearing potential will need to have a negative pregnancy test performed within 14 days prior to study procedure (if applicable) and be adherent to an accepted method of contraception.
15. Male subject will need to adhere to barrier contraception during the course of the trial and for 1 month after completion of the final injection of Cuvitru.
16. Ability to sign informed consent
Exclusion Criteria
2. Known hereditary/genetic/congenital defects, and autoimmune disease including hereditary spherocytosis, hereditary elliptocytosis, paroxysmal nocturnal hemoglobinuria, and sickle cell disease
3. Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
4. Chronic oral steroid use of prednisone treatment of ≥20 mg daily (or equivalent) will be excluded to ensure subject is medically stable.
5. Alpha-1 antitrypsin deficiency
6. Obesity with a BMI \> 40
7. Unstable hypertension systolic blood pressure (SBP) \>160 mmHg upon repeated measure
8. Diabetes mellitus Type I
9. Known history of acquired or inherited thrombophilia disorders
10. Known risk factors of hemolysis, including G6PD deficiency, mitral valve replacement, aortic valve replacement.
11. Known prolonged periods of immobilization
12. Known severe hypovolemia noted by SBP ≤ 85 and/or heart rate (HR) \>130
13. Known hypercoagulable conditions
14. Use of estrogens
15. Indwelling central vascular catheters
16. Currently actively smoking
18 Years
82 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Rochester General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
S. Shahzad Mustafa
Principle Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Syed S Mustafa, MD
Role: PRINCIPAL_INVESTIGATOR
Rochester General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rochester Regional Health Ctr for Clinical Research - Alexander Park
Rochester, New York, United States
Rochester Regional Health - Ctr for Clinical Research - Linden Oaks
Rochester, New York, United States
Rochester Regional Health - Ctr for Clinical Research - Greece
Rochester, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Toy EL, Gallagher KF, Stanley EL, Swensen AR, Duh MS. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010 Jun;7(3):214-28. doi: 10.3109/15412555.2010.481697.
Petrov AA, Adatia A, Jolles S, Nair P, Azar A, Walter JE. Antibody Deficiency, Chronic Lung Disease, and Comorbid Conditions: A Case-Based Approach. J Allergy Clin Immunol Pract. 2021 Nov;9(11):3899-3908. doi: 10.1016/j.jaip.2021.09.031. Epub 2021 Sep 28.
Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
Sethi S. Infection as a comorbidity of COPD. Eur Respir J. 2010 Jun;35(6):1209-15. doi: 10.1183/09031936.00081409.
Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, Anthonisen NR; COPD Clinical Research Network. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011 Aug 25;365(8):689-98. doi: 10.1056/NEJMoa1104623.
Putcha N, Paul GG, Azar A, Wise RA, O'Neal WK, Dransfield MT, Woodruff PG, Curtis JL, Comellas AP, Drummond MB, Lambert AA, Paulin LM, Fawzy A, Kanner RE, Paine R 3rd, Han MK, Martinez FJ, Bowler RP, Barr RG, Hansel NN; SPIROMICS investigators. Lower serum IgA is associated with COPD exacerbation risk in SPIROMICS. PLoS One. 2018 Apr 12;13(4):e0194924. doi: 10.1371/journal.pone.0194924. eCollection 2018.
McCullagh BN, Comellas AP, Ballas ZK, Newell JD Jr, Zimmerman MB, Azar AE. Antibody deficiency in patients with frequent exacerbations of Chronic Obstructive Pulmonary Disease (COPD). PLoS One. 2017 Feb 17;12(2):e0172437. doi: 10.1371/journal.pone.0172437. eCollection 2017.
Holm AM, Andreassen SL, Christensen VL, Kongerud J, Almas O, Auraen H, Henriksen AH, Aaberge IS, Klingenberg O, Rustoen T. Hypogammaglobulinemia and Risk of Exacerbation and Mortality in Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2020 Apr 16;15:799-807. doi: 10.2147/COPD.S236656. eCollection 2020.
Traister RS, Coffey K, Xie M, Van Meerbeke S, Pilewski JM, Sorensen RU, Petrov AA. Evaluation of humoral immunity in end-stage lung disease. J Allergy Clin Immunol Pract. 2020 Jun;8(6):2104-2106. doi: 10.1016/j.jaip.2020.01.063. Epub 2020 Feb 26. No abstract available.
Criner GJ, Connett JE, Aaron SD, Albert RK, Bailey WC, Casaburi R, Cooper JA Jr, Curtis JL, Dransfield MT, Han MK, Make B, Marchetti N, Martinez FJ, Niewoehner DE, Scanlon PD, Sciurba FC, Scharf SM, Sin DD, Voelker H, Washko GR, Woodruff PG, Lazarus SC; COPD Clinical Research Network; Canadian Institutes of Health Research. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014 Jun 5;370(23):2201-10. doi: 10.1056/NEJMoa1403086. Epub 2014 May 18.
Leitao Filho FS, Ra SW, Mattman A, Schellenberg RS, Criner GJ, Woodruff PG, Lazarus SC, Albert R, Connett JE, Han MK, Martinez FJ, Leung JM, Paul Man SF, Aaron SD, Reed RM, Sin DD; Canadian Respiratory Research Network (CRRN). Serum IgG subclass levels and risk of exacerbations and hospitalizations in patients with COPD. Respir Res. 2018 Feb 14;19(1):30. doi: 10.1186/s12931-018-0733-z.
Barr JT, Schumacher GE, Freeman S, LeMoine M, Bakst AW, Jones PW. American translation, modification, and validation of the St. George's Respiratory Questionnaire. Clin Ther. 2000 Sep;22(9):1121-45. doi: 10.1016/S0149-2918(00)80089-2.
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
Orange JS, Ballow M, Stiehm ER, Ballas ZK, Chinen J, De La Morena M, Kumararatne D, Harville TO, Hesterberg P, Koleilat M, McGhee S, Perez EE, Raasch J, Scherzer R, Schroeder H, Seroogy C, Huissoon A, Sorensen RU, Katial R. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2012 Sep;130(3 Suppl):S1-24. doi: 10.1016/j.jaci.2012.07.002.
Gold MS, Amarasinghe A, Greenhawt M, Kelso JM, Kochhar S, Yu-Hor Thong B, Top KA, Turner PJ, Worm M, Law B. Anaphylaxis: Revision of the Brighton collaboration case definition. Vaccine. 2023 Apr 6;41(15):2605-2614. doi: 10.1016/j.vaccine.2022.11.027. Epub 2022 Nov 24.
Related Links
Access external resources that provide additional context or updates about the study.
Global initiative for Chronic Obstructive Lung Disease
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IISR Protocol
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.