In: COPD14 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). canadian-familypharmacy.com
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|
|Duration of disease, yr|
|Percent of predicted normal|
Blog invites submissions of review articles, reports on clinical techniques, case reports, conference summaries, and articles of opinion pertinent to the control of pain and anxiety in dentistry.