Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations

Cowan, Juthaporn; Mulpuru, Sunita; Aaron, Shawn D.; Alvarez, Gonzalo G.; Giulivi, Antonio; Corrales–Medina, Vicente F.; Thiruganasambandamoorthy, Venkatesh; Thavorn, Kednapa; Mallick, Ranjeeta; Cameron, Donald W.

doi:10.1186/s40814-018-0327-z

Cited by 4 publications

(3 citation statements)

References 24 publications

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“…The trial was registered (ClinicalTrials.gov Identifier: NCT02690038, and NCT03018652), and its protocol was published. 13 The study received regulatory approval from Health Canada and ethics approval (Protocol 20150925–01H, 20160077–01H and 2017005–01H). All patients provided informed written consent prior to study participation in accordance with the Declaration of Helsinki.…”

Section: Methodsmentioning

confidence: 99%

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD

Cowan

Mulpuru

Abdallah

et al. 2021

COPD

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Background Observational studies suggest that immunoglobulin treatment may reduce the frequency of acute exacerbations of COPD (AECOPD). Objective To inform the design of a future randomised control trial (RCT) of intravenous immunoglobulin (IVIG) treatment efficacy for AECOPD prevention. Methods A pilot RCT was conducted. We recruited patients with COPD hospitalized for AECOPD, or from ambulatory clinics with one severe, or two moderate AECOPD in the previous year regardless of their serum IgG level. Patients were allocated in a 1:1 ratio with balanced randomisation to monthly IVIG or normal saline for 1 year. The primary outcome was feasibility defined as pre-specified accrual, adherence, and follow-up rates. Secondary outcomes included safety, tolerance, AECOPD rates, time to first AECOPD, quality of life, and healthcare costs. Results Seventy patients were randomized (37 female; mean age 67.7; mean FEV1 35.1%). Recruitment averaged 4.5±0.9 patients per month (range 0–8), 34 (49%) adhered to at least 80% of planned treatments, and four (5.7%) were lost to follow-up. There were 35 serious adverse events including seven deaths and one thromboembolism. None was related to IVIG. There were 56 and 48 moderate and severe AECOPD in the IVIG vs control groups. In patients with at least 80% treatment adherence, median time to first moderate or severe AECOPD was 275 vs 114 days, favoring the IVIG group (HR 0.76, 95% CI 0.3–1.92). Conclusion The study met feasibility criteria for recruitment and retention, but adherence was low. A trend toward more robust treatment efficacy in adherent patients supports further study, but future trials must address treatment adherence. Trial registration number NCT0290038, registered 24 February 2016, https://clinicaltrials.gov/ct2/show/NCT02690038 and NCT03018652, registered January 12, 2017, https://clinicaltrials.gov/ct2/show/NCT03018652 .

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Section: Methodsmentioning

confidence: 99%

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD

Cowan

Mulpuru

Abdallah

et al. 2021

COPD

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“…Anxiety in patients with COPD will be assessed by the Anxiety Inventory for Respiratory Disease scale (AIR scale) [ 41 ]. The scale has ten points (score range, 0 [best]–30 [worst]), and a score of greater than eight indicates a high level of anxiety [ 42 ].…”

Section: Methodsmentioning

confidence: 99%

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial

Shen

Guo

et al. 2021

Trials

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Background Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by coughing, the production of excess sputum, and dyspnea. Patients with excessively thick sputum may have frequent attacks or develop more serious disease. The guidelines recommend airway clearance for patients with excessive sputum who are hospitalized with COPD. The active cycle of breathing technique is the most common non-pharmacological airway clearance technique used by physiotherapists. However, the effectiveness of the technique is not always guaranteed. Active cycle of breathing techniques require the initial dilution of the sputum, usually by inhalation drugs, which may have limited effects. Recent studies have found that phonophoresis decreases inflammation, suggesting the potential of the combined usage of active cycle of breathing techniques and phonophoresis. Therefore, the aim of this study is to explore the effectiveness and safety of combining active cycle of breathing technique and phonophoresis in treating COPD patients. Methods and analysis We propose a single-blind randomized controlled trial using 75 hospitalized patients diagnosed with COPD with excessive sputum production. The patients will be divided into three groups. The intervention group will receive active cycle of breathing techniques combined with phonophoresis. The two comparison groups will be treated with active cycle of breathing techniques and phonophoresis, respectively. The program will be implemented daily for 1 week. The primary outcomes will be changes in sputum viscosity and production, lung function, and pulse oximetry. Secondary outcomes include the assessment of COPD and anxiety, measured by the COPD Assessment Test scale and the Anxiety Inventory for Respiratory Disease, respectively; self-satisfaction; the degree of cooperation; and the length of hospital stay. All outcome measures, with the exception of sputum production and additional secondary outcomes, will be assessed at the commencement of the study and after 1 week’s intervention. Analysis of variance will be used to investigate differences between the groups, and a p-value of less than 0.05 (two-tailed) will be considered statistically significant. Discussion This study introduces a combination of active cycle of breathing techniques and phonophoresis to explore the impact of these interventions on patients hospitalized with COPD. If this combined intervention is shown to be effective, it may prove to be a better treatment for patients with COPD. Trial registration The trial was registered prospectively on the Chinese Clinical Trial Registry on 24 December 2019.ClinicalTrials.gov ChiCTR1900028506. Registered on December 2019.

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“…A decrease in serum Ig levels in stable patients with COPD can potentially raise the frequency and severity of exacerbations and recurrent respiratory infections and increase their risk of mortality [ 15 , 16 , 17 ]. Ig replacement therapy in patients with COPD has been studied and has shown good initial results [ 18 ]. In Vietnam, the number of COPD patients is increasing, and the rate of re-hospitalization and death due to infections is relatively high, burdening the healthcare system.…”

Section: Introductionmentioning

confidence: 99%

Changes in Serum Immunoglobulin G Subclasses during the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Infectious Exacerbations

Viet

Nguyen

et al. 2022

ARM

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Introduction: Despite the theoretical importance of serum immunoglobulin (Ig) in the outcome of COPD exacerbations, the existing evidence for this has not been enough. This study was performed to evaluate changes in serum Ig levels and their relationship with outcomes of acute infectious exacerbations in patients with COPD. Methods: The prospective study was conducted at Military Hospital 103 from August 2017 to April 2019. Group D patients with COPD with infectious exacerbation were selected for participation in the study. The control group consisted of 30 healthy people. The patients were provided clinical examination and laboratory service; simultaneously, we measured their serum Ig levels (total IgG, IgG1, IgG2, IgG3, IgG4) at two time points: at admission (T1) and the final health outcome (T2). Results: The median levels of total IgG in patients at times T1 and T2 were significantly lower compared with those in the healthy group (1119.3 mg/dL and 1150.6 mg/dL compared with 2032.2 mg/dL) (p < 0.001). Regarding changes among IgG subclasses, the IgG1, IgG3, and IgG4 levels measured at T1 and T2 were reduced significantly compared with the control group (p < 0.05); the IgG3 levels at T1 were significantly higher than those at T2. IgG3 levels in patients with life-threatening exacerbations were significantly lower than the remaining ones (24.6 (26.8–155.5) mg/dL and 25.6 (29.5–161.2) mg/dL, respectively, p = 0.023). Conclusions: In group D patients with COPD with infectious exacerbations, there was a decrease in the serum IgG, IgG1, IgG3, and IgG4 levels. IgG3 levels were associated with the severity of COPD exacerbation.

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Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations

Cited by 4 publications

References 24 publications

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial

Changes in Serum Immunoglobulin G Subclasses during the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Infectious Exacerbations

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