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

In: COPD

16 Mar 2014

Routine Nebulized Ipratropium and Albuterol Together Are Better Than Either Alone in COPD: ObservationsObservations
Before entry and after the trial, each subject had a medical examination, blood and urine testing, and a 12-lead ECG to exclude other important disease problems and to monitor the safety of the study medication. Each subject performed peak flow measurements using a Wright peak flowmeter (Ferraris Medical; Holland, NY) twice daily, immediately after arising in the morning and between 4 and 6 pm at least 3 h after use of inhaled bronchodilator. Subjects were seen every 2 weeks to monitor adverse events, pulmonary function, clinical status, and concomitant medications. Pulmonary function testing, which included measurement of FEVX, FVC, and forced expiratory flow between 25% and 75% of the FVC (FEF25_75), was done on treatment days 1, 29, 57, and 85 immediately before study drug administration, 15, 30, and 60 min after drug administration, and hourly after that for a total of 8 h. canada viagra
Theophylline therapy was withheld for at least 24 h and treatment with the study drug was withheld for 12 h before testing. All spirometry was done in triplicate and the results with the greatest sum of FEVX and FVC were used for analysis. Patients were asked to report adverse effects and were not prompted to report any specific problems. At each visit, subjects completed a quality of life questionnaire as proposed by Guyatt et al. They recorded the current severity of symptoms (wheezing, coughing, chest tightness, and shortness of breath), and gave a global evaluation of overall condition (graded from l=poor to 8=excellent). The quality of life questionnaire evaluated dyspnea, fatigue, emotional function, and mastery.
Statistical Assessment
The primary efficacy analysis for this trial was the acute bronchodilator response. The spirometric response to inhaled drug, defined as the change from baseline on each test day, was the principal pulmonary function variable chosen. The main end points were the peak change from baseline and the area under the response-time curve (AUC) as calculated by the trapezoidal rule. The AUC was calculated for the intervals of 0 to 4 h, 4 to 6 h, 6 to 8 h, and the entire 8-h period after drug administration. The FEV responses were also portrayed in terms of onset, duration, and time of peak. Duration of action was determined as the time point at which a 15% increase over test-day baseline was present, providing that the response was not below 15% at both of the two immediate preceeding time points. The FEF25_75 and FVC were similarly evaluated. When patients could not complete 8 h of testing, the data were handled as follows: if testing was stopped early for reasons unrelated to COPD, the last recorded value on that test day was used for all subsequent missing values, provided at least 4 h of testing had been completed. If testing was halted because of lack of response, the lowest value observed for that patient on that test day was used for data following testing interruption.
The persistence of effect over the course of the investigation was assessed by comparing the FEVX responses on the various study days with those obtained on day 1 and by determining the percentages of subjects who responded on each test day. We included values only from patients who completed testing on all  4 days for this evaluation.


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