COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study
Gary T Ferguson,1 Mo Ghafouri,2 Luyan Dai,2 Leonard J Dunn31Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Clinical Research of West Florida, Inc, Clearwater, FL, USABackground: Ipratropium bromide/albuterol Res...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2013-03-01
|
| Series: | International Journal of COPD |
| Online Access: | http://www.dovepress.com/copd-patient-satisfaction-with-ipratropium-bromidealbuterol-delivered--a12500 |
| _version_ | 1819154396637822976 |
|---|---|
| author | Ferguson GT Ghafouri M Dai L Dunn LJ |
| author_facet | Ferguson GT Ghafouri M Dai L Dunn LJ |
| author_sort | Ferguson GT |
| collection | DOAJ |
| description | Gary T Ferguson,1 Mo Ghafouri,2 Luyan Dai,2 Leonard J Dunn31Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Clinical Research of West Florida, Inc, Clearwater, FL, USABackground: 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).Design: 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.Participants: Patients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD), and current or exsmokers.Interventions: 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.Main measures: Patient Satisfaction and Preference Questionnaire (PASAPQ) performance score (primary endpoint) and adverse events.Key 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.Conclusion: 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.Keywords: COPD, consumer satisfaction, consumer preference, inhalers |
| first_indexed | 2024-12-22T15:20:25Z |
| format | Article |
| id | doaj.art-711fbcda3c2348f0bdb2409c1f853dd6 |
| institution | Directory Open Access Journal |
| issn | 1176-9106 1178-2005 |
| language | English |
| last_indexed | 2024-12-22T15:20:25Z |
| publishDate | 2013-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of COPD |
| spelling | doaj.art-711fbcda3c2348f0bdb2409c1f853dd62022-12-21T18:21:38ZengDove Medical PressInternational Journal of COPD1176-91061178-20052013-03-012013default139150COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled studyFerguson GTGhafouri MDai LDunn LJGary T Ferguson,1 Mo Ghafouri,2 Luyan Dai,2 Leonard J Dunn31Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Clinical Research of West Florida, Inc, Clearwater, FL, USABackground: 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).Design: 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.Participants: Patients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD), and current or exsmokers.Interventions: 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.Main measures: Patient Satisfaction and Preference Questionnaire (PASAPQ) performance score (primary endpoint) and adverse events.Key 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.Conclusion: 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.Keywords: COPD, consumer satisfaction, consumer preference, inhalershttp://www.dovepress.com/copd-patient-satisfaction-with-ipratropium-bromidealbuterol-delivered--a12500 |
| spellingShingle | Ferguson GT Ghafouri M Dai L Dunn LJ COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study International Journal of COPD |
| title | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study |
| title_full | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study |
| title_fullStr | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study |
| title_full_unstemmed | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study |
| title_short | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study |
| title_sort | copd patient satisfaction with ipratropium bromide albuterol delivered via respimat a randomized controlled study |
| url | http://www.dovepress.com/copd-patient-satisfaction-with-ipratropium-bromidealbuterol-delivered--a12500 |
| work_keys_str_mv | AT fergusongt copdpatientsatisfactionwithipratropiumbromidealbuteroldeliveredviarespimatarandomizedcontrolledstudy AT ghafourim copdpatientsatisfactionwithipratropiumbromidealbuteroldeliveredviarespimatarandomizedcontrolledstudy AT dail copdpatientsatisfactionwithipratropiumbromidealbuteroldeliveredviarespimatarandomizedcontrolledstudy AT dunnlj copdpatientsatisfactionwithipratropiumbromidealbuteroldeliveredviarespimatarandomizedcontrolledstudy |