COPD Exacerbation AcutePhase 2NCT05764993
Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention
A Phase 2 study testing CUVITRU - Ig subcutaneous human 20% and Standard Medical Therapy in people with COPD Exacerbation Acute, run by Rochester General Hospital at 3 sites in United States.
Trial summary
To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- CUVITRU - Ig subcutaneous human 20% and Standard Medical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2023to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years and ≤ 82 years old.
- Patient that meet three (3) or more of the five (5) following criteria.
- Dyspnea ≥ 5 on a visual analog scale
- Respiratory rate ≥ 24 breaths per minute
- Heart rate ≥ 95 beats per minute
- Resting SaO2 < 92% breathing ambient air of the patient's usual oxygen prescription and/or change in saturation > 3% from baseline
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- CRP ≥ 10 mg/L
- Established diagnosis of COPD with PFTs showing FEV1/FVC < 70% or FEV1/VC ratio below the 5th percentile of the predicted value.[14]
- 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.
- 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
- Medically stable with no acute hospitalizations for non-COPD related events within the last 3 months
- Expected life expectancy > 1 year
- Stable Cardiovascular Disease, with no planned intervention
- No history of pulmonary embolism or embolic event
- Hepatic function < Class B Child-Pugh criteria
- Renal insufficiency with eGFR > 60 mL/min/1.73m2
- No history of DVT or thrombotic events
- No history of prior organ transplant
- 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.
- 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.
- Ability to sign informed consent
Who cannot join
- Known history of humoral dysfunction/immunodeficiency
- Known hereditary/genetic/congenital defects, and autoimmune disease including hereditary spherocytosis, hereditary elliptocytosis, paroxysmal nocturnal hemoglobinuria, and sickle cell disease
- Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
- Chronic oral steroid use of prednisone treatment of ≥20 mg daily (or equivalent) will be excluded to ensure subject is medically stable.
- Alpha-1 antitrypsin deficiency
- Obesity with a BMI > 40
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- Unstable hypertension systolic blood pressure (SBP) >160 mmHg upon repeated measure
- Diabetes mellitus Type I
- Known history of acquired or inherited thrombophilia disorders
- Known risk factors of hemolysis, including G6PD deficiency, mitral valve replacement, aortic valve replacement.
- Known prolonged periods of immobilization
- Known severe hypovolemia noted by SBP ≤ 85 and/or heart rate (HR) >130
- Known hypercoagulable conditions
- Use of estrogens
- Indwelling central vascular catheters
- Currently actively smoking
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Rochester Regional Health Ctr for Clinical Research - Alexander Park
Rochester, New York, 14607
Dawn Sheflin, RN, 585-922-8314, Dawn.Sheflin@RochesterRegional.or
Holly Blue, LPN, 585-922-8314, Holly.Blue@RochesterRegional.org
- Recruiting
Rochester Regional Health - Ctr for Clinical Research - Linden Oaks
Rochester, New York, 14625
Dawn Sheflin, RN, 585-922-8314, Dawn.Sheflin@RochesterRegional.org
Holly Blue, LPN, 585-922-8314, Holly.Blue@RochesterRegional.org
- Recruiting
Rochester Regional Health - Ctr for Clinical Research - Greece
Rochester, New York, 14626
Dawn Sheflin, RN, 585-922-8314, Dawn.Sheflin@RochesterRegional.org
Holly Blue, LPN, 585-922-8314, Holly.Blue@RochesterRegional.org
About this study
Official title: Prevalence of Humoral Immune Deficiency in Patients With Frequent Exacerbations of COPD, and the Effect of Immunoglobulin Replacement on Future Exacerbations
To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses. Patients with COPD and humoral dysfunction will be offered treatment with Subcutaneous Immune Globulin Replacement Therapy (SCIgR) in an attempt to decrease future AECOPD.
Read the detailed description
This will be a non-blinded, randomized study. Patients with COPD will be referred for evaluation by outpatient pulmonary clinics at Rochester Regional health. Following informed consent all patients will be evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptides antigens (diphtheria and tetanus) with Td as well as polysaccharide antigens (streptococcus pneumoniae) with pneumococcus polyvalent vaccine-23 (PPV23). Patients with COPD and pre-defined humoral dysfunction (please see below) will be randomized in 1:1 ratio to one of two groups until approximately 20 patients per group are accrued for a total of 40 patients
Group #1: SCIgR with Cuvitru 125 mg/kg/week + standard of care management = 20 patients
Group #2: Standard of care management = 20 patients
- Conditions
- COPD Exacerbation Acute
- Being tested
- CUVITRU - Ig subcutaneous human 20%, Standard Medical Therapy
- Keywords
- humoral dysfunction, humoral immune function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUVITRU - Ig subcutaneous human 20%Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution
Subcutaneous Immunoglobin Replacement Therapy, SCigR
Standard Medical TherapyOther
Standard Medical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group #1 | Experimental | SCIgR with Cuvitru 125 mg/kg/week + standard of care management Receives: Biological: CUVITRU - Ig subcutaneous human 20%; Other: Standard Medical Therapy |
| Group #2 | Placebo comparator | Standard of care management = 20 patients Receives: Other: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AECOPD requiring treatment with systemic steroids over one year
AECOPD is defined by increased respiratory symptoms (e.g., cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids.
Measured: one year
Secondary outcomes (1)
COPD with pre-defined humoral dysfunction treated with subcutaneous SCIgR will have decreased AECOPD events as compared to COPD with pre-defined humoral dysfunction treated with the standard of care (SOC) management.
AECOPD events will be determined by evaluating the rate of re-hospitalization in both treatment groups (ie with subcutaneous SCIgR + SOC versus SOC). The treatment group with subcutaneous SCIgR + SOC will have decreased AECOPD events as evidenced by the lower rehospitalization rate in comparison to the SOC treatment group's rehospitalization rate.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Jun 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-blinded, randomized study. Patients with COPD will be referred for evaluation by outpatient pulmonary clinics at Rochester Regional health. Following informed consent all patients will be evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptides antigens (diphtheria and tetanus) with Td as well as polysaccharide antigens (streptococcus pneumoniae) with pneumococcus polyvalent vaccine-23 (PPV23). Patients with COPD and pre-defined humoral dysfunction (please see below) will be randomized in 1:1 ratio to one of two groups until approximately 20 patients per group are accrued for a total of 40 patients
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, S. Shahzad Mustafa, Rochester General Hospital
- Investigators
- Syed S Mustafa, MD, Principal investigator, Rochester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764993
- Sponsor's protocol ID
- IISR Protocol
- Status last verified
- Jun 2023
- First submitted
- 29 Nov 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20486821Petrov 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.
PubMed 34592394Sethi 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.
PubMed 19038881Sethi S. Infection as a comorbidity of COPD. Eur Respir J. 2010 Jun;35(6):1209-15. doi: 10.1183/09031936.00081409.
PubMed 20513910Albert 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.
PubMed 21864166Putcha 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.
PubMed 29649230McCullagh 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.
PubMed 28212436Holm 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.
PubMed 32368026Traister 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.
PubMed 32112921Criner 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.
PubMed 24836125Leitao 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.
PubMed 29444682Barr 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.
PubMed 11048909Pellegrino 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.
PubMed 16264058Orange 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.
PubMed 22935624Gold 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.
PubMed 36435707
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Humoral Immune Deficiency in Patients With Frequent Exacerbations of COPD, and the Effect of Immunoglobulin Replacement on Future Exacerbations
- ClinicalTrials.gov ID
- NCT05764993
- Acronym / sponsor ID
- IISR Protocol
- Conditions
- COPD Exacerbation Acute
- Keywords
- humoral dysfunction, humoral immune function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rochester General HospitalUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses. Patients with COPD and humoral dysfunction will be offered treatment with Subcutaneous Immune Globulin Replacement Therapy (SCIgR) in an attempt to decrease future AECOPD.
Detailed description
This will be a non-blinded, randomized study. Patients with COPD will be referred for evaluation by outpatient pulmonary clinics at Rochester Regional health. Following informed consent all patients will be evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptides antigens (diphtheria and tetanus) with Td as well as polysaccharide antigens (streptococcus pneumoniae) with pneumococcus polyvalent vaccine-23 (PPV23). Patients with COPD and pre-defined humoral dysfunction (please see below) will be randomized in 1:1 ratio to one of two groups until approximately 20 patients per group are accrued for a total of 40 patients
Group #1: SCIgR with Cuvitru 125 mg/kg/week + standard of care management = 20 patients
Group #2: Standard of care management = 20 patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-blinded, randomized study. Patients with COPD will be referred for evaluation by outpatient pulmonary clinics at Rochester Regional health. Following informed consent all patients will be evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptides antigens (diphtheria and tetanus) with Td as well as polysaccharide antigens (streptococcus pneumoniae) with pneumococcus polyvalent vaccine-23 (PPV23). Patients with COPD and pre-defined humoral dysfunction (please see below) will be randomized in 1:1 ratio to one of two groups until approximately 20 patients per group are accrued for a total of 40 patients
| Arm | Type | Receives |
|---|---|---|
| Group #1 | Experimental | Biological: CUVITRU - Ig subcutaneous human 20%, Other: Standard Medical TherapySCIgR with Cuvitru 125 mg/kg/week + standard of care management |
| Group #2 | Placebo comparator | Other: Standard Medical TherapyStandard of care management = 20 patients |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients > 18 years and ≤ 82 years old.
- Patient that meet three (3) or more of the five (5) following criteria.
- Established diagnosis of COPD with PFTs showing FEV1/FVC < 70% or FEV1/VC ratio below the 5th percentile of the predicted value.[14]
- 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.
- 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
Key exclusion criteria (16 listed)
- Known history of humoral dysfunction/immunodeficiency
- Known hereditary/genetic/congenital defects, and autoimmune disease including hereditary spherocytosis, hereditary elliptocytosis, paroxysmal nocturnal hemoglobinuria, and sickle cell disease
- Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
- Chronic oral steroid use of prednisone treatment of ≥20 mg daily (or equivalent) will be excluded to ensure subject is medically stable.
- Alpha-1 antitrypsin deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUVITRU - Ig subcutaneous human 20%Also: Immune Globulin Subcutaneous (Human), 20% SolutionSubcutaneous Immunoglobin Replacement Therapy, SCigR | Biological | Group #1 |
| Standard Medical TherapyStandard Medical Therapy | Other | Group #1, Group #2 |
Primary outcome
AECOPD requiring treatment with systemic steroids over one year
Time frame: one year
AECOPD is defined by increased respiratory symptoms (e.g., cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids.
1 secondary outcome
COPD with pre-defined humoral dysfunction treated with subcutaneous SCIgR will have decreased AECOPD events as compared to COPD with pre-defined humoral dysfunction treated with the standard of care (SOC) management.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 20486821Toy 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.
- Background: PubMed 34592394Petrov 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.
- Background: PubMed 19038881Sethi 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.
- Background: PubMed 20513910Sethi S. Infection as a comorbidity of COPD. Eur Respir J. 2010 Jun;35(6):1209-15. doi: 10.1183/09031936.00081409.
- Background: PubMed 21864166Albert 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.
- Background: PubMed 29649230Putcha 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.
- Background: PubMed 28212436McCullagh 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.
- Background: PubMed 32368026Holm 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.
- Background: PubMed 32112921Traister 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.
- Background: PubMed 24836125Criner 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.
- Background: PubMed 29444682Leitao 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.
- Background: PubMed 11048909Barr 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.
- Global initiative for Chronic Obstructive Lung DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed S Mustafa, MD principal investigator
Rochester General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CUVITRU - Ig subcutaneous human 20% and Standard Medical Therapy in people with COPD Exacerbation Acute, run by Rochester General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn Sheflin, RN (585-922-8314, Dawn.Sheflin@RochesterRegional.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AECOPD requiring treatment with systemic steroids over one year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764993, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.