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COPD Evaluation


Wednesday, November 2, 2005

12:30 PM - 2:00 PM

PATIENT-REPORTED SYMPTOMS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN CLINICAL TRIALS

Steven Kesten, MD* and Shailendra Menjoge, PhD

Boehringer Ingelheim, Ridgefield, CT

PURPOSE: Several respiratory symptoms are associated with COPD. We sought to determine the symptom most frequently perceived by patients to be the first symptom and the most troublesome of COPD and to identify patient characteristics associated with these perceptions.

METHODS: An evaluation of pooled data was conducted from three clinical trials of tiotropium in COPD (205.264, 205.266, 205.284) in which patients reported the features of their disease at baseline. The trials had common inclusion criteria (age ≥40 years, diagnosis of COPD, no history of asthma, FEV1/FVC ≤70%, FEV1 ≤60 to 65% predicted, smoking ≥10 pack-years). Data are expressed descriptively as means or proportions.

RESULTS: There were 2,678 patients. Dyspnea was the most commonly reported first and most troublesome COPD symptom. In patients also reporting chronic bronchitis, the first symptom and most troublesome symptom was dyspnea (71% and 86%, respectively) followed by cough (19% and 8%, respectively). In patients also reporting emphysema, the first symptom and most troublesome symptom was dyspnea (77% and 90%, respectively) followed by cough (14% and 5%, respectively). Baseline data are displayed below according to the patient-reported first or most troublesome symptom:.

CONCLUSION: Dyspnea is the first symptom and the most troublesome symptom of COPD and is reported as such irrespective of demographics and diagnoses of either chronic bronchitis and/or emphysema. In general, baseline demographic characteristics are unable to adequately distinguish which symptom patients will report as their most troublesome.

CLINICAL IMPLICATIONS: The focus of clinical research in COPD should include evaluations of dyspnea as this appears to be the first and most troublesome symptom to COPD patients with differing demographic features.

DISCLOSURE: Steven Kesten, Employee S. Kesten and S. Menjoge are employees of Boehringer Ingelheim.; Grant monies (from industry related sources) Study 205.264 and 205.266 were funded by Boehringer Ingelheim and Pfizer. Study 205.284 was funded by Boehringer Ingelheim.


First Symptom

% of total Dyspnea N=2033 75.9% Cough N=400 14.9% Wheeze N=113 4.2% Sputum N=43 1.6% Other N=89 3.3%

% women/% men 12/88 17/83 12/89 7/93 12/88
FEV1 (L) 1.03 1.06 1.04 1.06 1.04
FEV1 predicted (%) 36.0 37.9 36.6 12.0 13.1
COPD duration (yrs) 10.9 12.4 12.6 12.9 13.2
Former smoker (%) 69.7 63.0 65.5 67.4 73.0
Smoking history (pack-yrs) 65.2 66.6 58.9 58.4 68.5


Most Troublesome Symptom

% of total Dyspnea N=2376 88.7% Cough N=168 6.3% Wheeze N=46 1.7% Sputum N=60 2.2% Other N=28 1.0%

% women / % men 12/88 16/84 15/85 10/90 25/75
FEV1 (L) 1.02 1.19 1.21 1.22 1.07
FEV1 predicted (%) 35.7 42.1 42.0 42.8 37.9
COPD duration (yrs) 11.3 11.0 14.1 11.5 9.6
Former smoker (%) 70.0 54.2 50.0 66.7 67.9
Smoking history (pack-yrs) 65.5 62.2 69.1 67.8 57.8







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