A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations
Completed · Phase 1
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.
Key facts
- Study ID
- NCT00116402
- Run by
- University of Chicago
- People needed
- 15
- Starts
- 2005-01-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2014-08-05
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females > 50 years of age
- Physiologic evidence of COPD defined per ATS guidelines as: cigarette smoking history >20 pack years, FEV1/FVC <70%
- Patients must have a post-bronchodilator FEV1 >50% of predicted value at enrollment
- Patient must have an O2 saturation measure by pulse oximetry >90% on RA
- Must be able to participate in the study, willing to give informed consent, and comply with the study restrictions
You may not qualify if…
- Women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy
- Observation of any solitary nodule in the lung requiring further medical intervention
- Patients on maintenance therapy with oral steroids
- Patients with giant bullous disease
- Significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests
- Presence of a coagulopathy as defined by a platelet count <100,000/mm3, and PT and PTT >1.2 x the upper limit of normal
- Concurrent enrollment or participation in any other clinical trials within the past 30 days
- Primary diagnosis of asthma
- History of alpha 1 antitrypsin deficiency
- Any clinically significant and active pulmonary disease that could contribute to dyspnea
- Current systemic and inhaled steroids and theophylline
Where it is running
- Department of Medicine, Pulmonary & Critical Care Section, The University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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