Routine Nebulized Ipratropium and Albuterol Together Are Better Than Either Alone in COPD: Materials and Methods


14 Mar 2014

Design and Conduct of the Study
Twenty-five clinical centers participated in this project. Each center conformed to the institutional review board and informed consent provisions of the code of federal regulations. We compared the safety and efficacy, including persistence of broncho-dilator action, of inhalation solutions of IB, albuterol sulfate, and of the combination IB and albuterol during an 85-day treatment period. The subjects were patients with a diagnosis of COPD who were at least 40 years old and had a smoking history of at least 10 pack-years. Each participant was required to have stable airway obstruction with an FEV1 <65% predicted normal and <70% of the FVC. We required study patients to be taking at least two prescribed therapeutic agents for control of their COPD symptoms for at least 3 months before participation in the trial. Persons with a history of asthma, allergic rhinitis, or atopy, or who had a total eosinophil count >500/mm³ were excluded. We selected and randomized 652 patients into the trial: 214 received IB, 216 received albuterol, and 222 received the combination therapy (Table 1).

Following a 2-week baseline period to establish clinical stability, patients were randomly assigned within each center by order of entry to receive either the IB inhalation solution (0.5 mg), albuterol sulfate inhalation solution (3.0 mg), or the combination IB-albuterol inhalation solution using blocks of six patients. Subjects took medication three times daily. This was a doubleblind study in which the medication consisted of 2.5 mL from identically appearing unit dose vials that was delivered by a compressor-driven nebulizer (DeVilbiss 646; Somerset, Pa) for 15 minutes or until there was no more medication. We allowed patients to take up to two extra doses of study medication per day for control of symptoms. Investigators could increase or add corticosteroids for two periods of up to 5 days each during exacerbations. Continued use of stable doses of theophylline was allowed, but use of inhaled bronchodilator other than study drug was not permitted.

Table 1—Baseline Values and Demographics of All Randomized Patients

IB and Albuterol IB Albuterol Overall
Total randomized and treated 222 214 216 652
Age, yr
Mean 65.5 64.8 64.6 64.9
Range 41-83 44-86 41-85 41-86
Male 146 136 142 424
Female 76 78 74 228
White 202 202 202 606
Black 18 11 11 40
Other 2 1 3 6
Height, cm
Mean 167.5 167.5 167.5 167.5
Range 142.5-197.5 142.5-195 142.5-192.5 142.5-197.5
Duration of disease, yr
Mean 9.5 10.1 8.9 9.5
Range 0.5-45.0 0.25-45.0 0.5-40.0 0.25-45.0
Mean 0.918 0.907 0.910 0.912
Range 0.30-2.49 0.18-2.11 0.21-2.18 0.18-2.49
Percent of predicted normal
Mean 34.9 34.1 34.1 34.4
Range 11.1-64 9.4-69.9 9.2-64.4 9.2-64.4
Mean 44.1 43.7 44.2 44.0
Range 21.3-78.7 18.4-77.0 23.4-81.3 18.4-81.3

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