title: COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study.
abstract: BACKGROUND
  Ipratropium 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.
  
  
  OBJECTIVE
  The 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).
  
  
  METHODS
  This is a 48-week, open-label, randomized, active-controlled, parallel-group study (n = 470) comparing CVT-R to CVT-MDI and to I + A.
  
  
  METHODS
  Patients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD), and current or exsmokers.
  
  
  METHODS
  Patients 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.
  
  
  METHODS
  Patient Satisfaction and Preference Questionnaire (PASAPQ) performance score (primary endpoint) and adverse events.
  
  
  RESULTS
  PASAPQ 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.
  
  
  CONCLUSIONS
  CVT-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.
authors: Pulmonary Research Institute of Southeast Michigan, Livonia, MI 48152, USA. garytferguson@msn.com
authors: Gary T
authors: GT
authors: Ferguson
authors: Mo
authors: M
authors: Ghafouri
authors: Luyan
authors: L
authors: Dai
authors: Leonard J
authors: LJ
authors: Dunn
mesh_terms: D000328:Adult; D000368:Aged; D058109:Airway Management / Q000295:instrumentation*; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D016503:Drug Delivery Systems / Q000145:classification / Q000379:methods / Q000592:standards; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D004869:Equipment Safety; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D036501:Metered Dose Inhalers / Q000592:standards*; D008875:Middle Aged; D009330:Nebulizers and Vaporizers / Q000592:standards*; D057240:Patient Preference; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D009241:Ipratropium; D000420:Albuterol
keywords: COPD; consumer preference; consumer satisfaction; inhalers
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