Table 2.
Study characteristics of all studies included in the systematic review†
| Study | Study design | Demographic characteristics | Intervention | Baseline clinical characteristics | ||
|---|---|---|---|---|---|---|
| Measured baseline characteristics | Treatment group | Control group | ||||
| Baleeiro and Mull [32]31 |
Study Design: Case series (Abstract only) Enrollment Dates: 2007–2010 Location: United States Funding: NR Possible Conflicts of Interest: NR |
N of COPD patients = 17 patients Method of Recruitment: Clinic patients Sex: NR Mean Age (SD): NR Smoking History: Most cases tobacco related Comorbidities: Bronchiecstasis, CVID |
Treatment Group: Treatment Administration: IVIG or SCIG Dosage: NR Duration of intervention: NR |
PFT, Ig, and other parameters of interest were not reported |
PFT Results: NR Ig Levels: NR Other Parameters: NR |
No control group |
| Cowan et al. [33]29 |
Study Design: Retrospective Case series Enrollment Dates: 2008 – 2014 Location: Canada Funding: None Possible Conflicts of Interest: None |
N of COPD patients = 14 patients (out of 33 subjects with COPD that had Ig treatment). (Among exclusions: 11 not firm diagnosis of COPD, 5 had incomplete records, 3 excluded because < 3 months treatment due to intolerance of therapy) Method of Recruitment: Other: Review of medical records Sex: 6 (43%) males, 8 (57%) females Mean Age (SD): 67.1 ± 12.1 Smoking History: NR Comorbidities: 8 cases bronchiectasis 7 cases with asthma 5 cases obese (BMI > 30) 2 CAD 1 diabetes 1 monoclonal gammopathy No control group |
Treatment Administration: 6 on IVIG, 7 on SCIG, 1 switched from IVIG to SCIG due to intolerance Dosage: 0.5 ± 0.3 g/kg/month Duration of intervention: 363.1 ± 6.9 days |
FEV1, L/sec: FEV1, %: FEV1/FVC, %: N patients with severe COPD Mean serum IgG, g/L Mean serum IgG < 7 g/L Mean serum IgG < 5 g/L Other Parameters: Mean rate of moderate/severe AECOPD per year: Mean rate of moderate AECOPD per year: Mean rate of severe AECOPD per year: |
PFT Results: 1.2 ± 0.8 46.3 ± 18.6 43.4 ± 15.3 8 Ig Levels: 6.2 ± 2.2 9 (hypogammaglobulinemia) 5 out of the 9 (significant hypogammaglobulinemia Other Parameters: 4.65 3.8 (53 total exacerbations) 0.86 (12 total hospitalizations) 12 hospital admissions occurred in seven of fourteen cases |
No control group |
| Cowan et al. [35]32 |
Study Design: RCT Enrollment Dates: September 2016 (inpatients) and March 2018 (outpatients) -Nov 2018 Location: Canada Funding: The Ottawa Hospital Academic Medical Organization Innovative Fund, CSL Behring, and Grifols, with JC receiving grants and/or personal fees from the mentioned organizations – funders not involved in study design, conduct, analysis or interpretation |
(444 assessed—failed inclusion criteria (159), refused research (114), failed exclusion criteria (75) failed both inclusion and exclusion criteria (21) died while admitted (5) Treatment Group: N of COPD patients = 35 Method of Recruitment: Inpatients and clinic patients Sex: 20 males:15 females Mean Age (SD): 66.7 ± 7.4 years Smoking History: Pack years = 56.8 ± 27.5 Comorbidities: - Hypertension = 57% - Coronary artery disease = 26% - Congestive heart failure = 11% - Cardiomyopathy = 8% Control Group: N of COPD patients = 35 Method of Recruitment: Inpatients and clinic patients Sex: 13 male:22 female Mean Age (SD): 68.7 ± 8.7 years Smoking History: Pack years = 51.3 ± 29.8 Comorbidities:—Hypertension = 57% - Coronary artery disease = 43% - Congestive heart failure = 3% - Cardiomyopathy = 8% |
Treatment Group: Received IVIG (10% solution) q4 ± 1 weeks for 48 weeks Dose: 0.8 g/kg for hospitalized patients with hypogammaglobulinemia, and 0.5 g/kg for all others Control Group: Received IV Normal Saline (NS) q4 ± 1 weeks for 48 weeks Dose: same volume with what they would need if received IVIG In both cases: 1st dose in hospital for inpatients—all other doses at clinical investigation unit |
FEV1, L (%): FEV1/FVC, %: IgG, g/L: IgM, g/L: IgA, g/L: IgE, mg/L Other Parameters: Total number of AECOPD, number/year: Moderate AECOPD (managed as outpatient), number/year: Moderate AECOPD (ED visit), number/year: Severe AECOPD (hospitalization), number/year: |
PFT Results: 0.90 ± 0.39(34 ± 13) 42 ± 12 Ig Levels: 8.94 ± 2.83 0.85 ± 0.76 2.69 ± 1.15 0.96 ± 1.52 Other Parameters: 2.7 ± 1.3 1.37 ± 1.44 0.34 ± 0.68 1.1 ± 0.8 |
PFT Results: 0.87 ± 0.4(35 ± 14) 43 ± 16 Ig Levels: 7.34 ± 1.64 0.79 ± 0.56 2.17 ± 1.27 0.35 ± 0.57 Other Parameters: 2.5 ± 1.3 0.86 ± 1.04 0.26 ± 0.56 1.4 ± 0.81 |
| McCullagh et al. [34]30 |
Study Design: Case series Enrollment Dates: January 2012 (January 2010 for the retrospective chart review patients) -Dec 2014 Location: United States Funding: None Possible Conflicts of Interest: None |
N of COPD patients = 7 patients are included in the case series and retrospective chart review Therapeutic effect: 7 on IVIG (although the immune diagnosis was associated with the chosen therapy) (3 out of 7 of these patients were also on prophylactic antibiotics Treatment Group: N of COPD patients = IVIG (7) Method of Recruitment: Other: Clinic patients and Retrospective chart review Sex: NR Mean Age (SD): NR Smoking History: pack years, median (Range): 54 (30–75) Comorbidities: Total - All with CVID |
Treatment Group: Treatment Administration: IVIG OR SCIG for patients with CVID Dosage: IVIG was administered every 3 or 4 weeks, and SCIG was administered every 1 or 2 weeks The total dose of IVIG or SCIG ranged from 300 to 600 mg/KG/4-week period Duration of intervention: - 1 year |
FVC (Range) FEV1 (Range) FEV1/FVC (Range) IgA, g/L (Range) IgG, g/L (Range) IgM, g/L (Range) Other Parameters: |
PFT Results: 64.3 (59–68) (n = 3) 41.8 (28–60) (n = 4) 42.3 (30–62) (n = 4) Ig Levels: 0.793 (0.04–2.26) 3.556 (1.11–7.64) 0.359 (0.05–0.63) Other Parameters: NR |
No control group |
AECOPD; acute exacerbations of COPD, NR; not reported