COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study

Abstract

BackgroundIpratropium bromide/albuterol Respimat inhaler (CVT-R) was developed as an environmentally friendly alternative to ipratropium bromide/albuterol metered-dose inhaler (CVT-MDI), which uses a chlorofluorocarbon propellant.ObjectiveThe objective of this study was to evaluate patient satisfaction, device usage, and long-term safety of CVT-R compared to CVT-MDI, and to the simultaneous administration of ipratropium bromide hydrofluoroalkane (HFA; I) and albuterol HFA (A) metered-dose inhalers as dual monotherapies (I + A).DesignThis is a 48-week, open-label, randomized, active-controlled, parallel-group study (n = 470) comparing CVT-R to CVT-MDI and to I + A.ParticipantsPatients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD), and current or exsmokers.InterventionsPatients were randomized to receive: (1) CVT-R, one inhalation four times daily (QID); or (2) CVT-MDI, two inhalations QID; or (3) I + A two inhalations of each inhaler QID.Main measuresPatient Satisfaction and Preference Questionnaire (PASAPQ) performance score (primary endpoint) and adverse events.Key resultsPASAPQ performance score was significantly higher (CVT-R versus CVT-MDI, 9.6; and CVT-R versus I + A, 6.2; both P < 0.001) when using CVT-R compared to CVT-MDI or I + A at all visits starting from week 3, while CVT-MDI and I + A treatment groups were similar. Time to first COPD exacerbation was slightly longer in the CVT-R group compared to the other treatment groups, although it did not reach statistical significance (CVT-R versus CVT-MDI, P = 0.57; CVT-R versus I + A, P = 0.22). Rates of withdrawal and patient refusal to continue treatment were lower in CVT-R compared with CVT-MDI and I + A groups (CVT-R versus CVT-MDI, P = 0.09; CVT-R versus I + A, P = 0.005). The percentage of patients reporting adverse events and serious adverse events was similar across all three treatment groups.ConclusionCVT-R is an effective, environmentally friendly inhaler that provides patients with a high level of user satisfaction and may positively impact clinical outcomes while having no adverse impacts on patients using the device.

Efficiency of Ipratropium Bromide and Albuterol Deposition in the Lung Delivered via a Soft Mist Inhaler or Chlorofluorocarbon Metered‐Dose Inhaler

“…The Respimat inhaler was first launched in Europe in 2004 to deliver ipratropium bromide and the long‐acting β 2 ‐agonist bronchodilator, fenoterol hydrobromide (Berodual Respimat), and in 2007 to deliver tiotropium (Spiriva Respimat) for the treatment of patients with COPD; this device has since been used in a large number of patients with COPD . Compared with pMDIs, the Respimat inhaler has also been shown to be preferred by patients …”

“…demonstrated that ipratropium bromide 20 μg/albuterol 100 μg CVT‐R (CVT‐R 20/100) administered four times daily for 12 weeks provided equivalent bronchodilator efficacy and comparable safety to ipratropium bromide 36 μg/albuterol sulfate 206 μg CVT‐MDI (CVT‐MDI 36/206), and that lung function was significantly improved compared with the single‐component ipratropium bromide 20 μg Respimat inhaler (I‐R 20). Ferguson et al ., in an open‐label, 1‐year study evaluating patient satisfaction, device use, and long‐term safety of CVT‐R compared with CVT‐MDI or the free combination of ipratropium bromide HFA pMDI and albuterol sulfate HFA pMDI, showed comparable efficacy and safety, but greater patient satisfaction with CVT‐R compared with the other treatments.…”

“…The Respimat inhaler was first launched in Europe in 2004 to deliver ipratropium bromide and the long-acting β 2 -agonist bronchodilator, fenoterol hydrobromide (Berodual Respimat), and in 2007 to deliver tiotropium (Spiriva Respimat) for the treatment of patients with COPD; this device has since been used in a large number of patients with COPD. [12][13][14][15][16][17] Compared with pMDIs, the Respimat inhaler has also been shown to be preferred by patients. 17,18 The Respimat inhaler delivers active drug in an aqueous solution by generating a slow-moving aerosol cloud with a longer mean duration (1.5 s vs. 0.15-0.36 s) and a slower velocity (0.8 m/s vs. 2.0-8.4 m/s) than pMDIs, 6 allowing patients more time to synchronize actuation with inhalation more effectively.…”

“…[12][13][14][15][16][17] Compared with pMDIs, the Respimat inhaler has also been shown to be preferred by patients. 17,18 The Respimat inhaler delivers active drug in an aqueous solution by generating a slow-moving aerosol cloud with a longer mean duration (1.5 s vs. 0.15-0.36 s) and a slower velocity (0.8 m/s vs. 2.0-8.4 m/s) than pMDIs, 6 allowing patients more time to synchronize actuation with inhalation more effectively. To enhance lung penetration, the Respimat inhaler was designed to aerosolize the metered dose with droplets mostly within the respirable size range >1 μm to <5.8 μm.…”

“…21 CVT-R was approved in the United States by the FDA in October 2011, and is indicated for use in patients with COPD, who are on a regular aerosol bronchodilator, and continue to have evidence of bronchospasm and require a second bronchodilator. 23 In a randomized, double-blind, placeboand active-controlled study, ZuWallack et al 16 Ferguson et al, 17 in an open-label, 1-year study evaluating patient satisfaction, device use, and long-term safety of CVT-R compared with CVT-MDI or the free combination of ipratropium bromide HFA pMDI and albuterol sulfate HFA pMDI, showed comparable efficacy and safety, but greater patient satisfaction with CVT-R compared with the other treatments.…”