clinical Trials - General Medicine

Chronic Obstructive Pulmonary Disease (COPD):

This trial is for patients with Chronic Obstructive Pulmonary Disease with symptoms of COPD for more than two years. Patients must be current or previous smokers. The trial compares two doses of Symbicort with Formoterol. The purpose of the medications is to prevent worsening of the COPD. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Signed Informed Consent at Visit 1 obtained prior to conducting any study-related procedures including withdrawal of medications.
Outpatients; men or women > 40 years of age.
A current clinical diagnosis of COPD with COPD symptoms for more than 2 years.
Current or previous smoker with a smoking history equivalent to 10 or more pack years.
Pre-bronchodilator FEV1 < 50% of predicted normal value.
Pre-bronchodilator FEV1/FVC < 70%.
Documented use of a short-acting inhaled bronchodilator as rescue medication prior to study.
A score of > 2 or the MMRC dyspnea scale at Visit 2.
A history of at lease 1 COPD exacerbation requiring a course of steroids and/or antibiotics within 1-12 months before Visit 1.
Ability to comply with all study procedures and to satisfactorily take study medication.
Able to read and write and use the electronic devices.

The following criteria would exclude a patient from this trial:

A history of asthma at or after 18 years of age.
A history of allergic rhinitis at or after 18 years of age.
Subjects with significant or unstable ischemic heart disease, arrhythmia, etc.
Known homozygous alpha-1 antitrypsin deficiency.
Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject’s ability to participate in the study.
A history of malignancy (except basal cell carcinoma) within the past 5 years.
Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 30 days prior to Visit 1.
Subjects taking oral or ophthalmic non-cardioselective beta-blocking agents.
Subjects taking oral steroids.
Subjects who are currently in the intensive rehabilitation phase or scheduled to begin new participation in a COPD rehabilitation program during the study or have started a new COPD program within 60 days of Visit 1.
Known or suspected hypersensitivity to the study therapy or excipients of the investigational products.
Planned hospitalization during the study.
Pregnancy, breast-feeding or planned pregnancy during the study; fertile women not using acceptable contraceptive measures, as judged by the investigator. Females who are not post-menopausal or surgically sterile must have a negative pregnancy test prior to randomization.
Subjects who have participated in a clinical study evaluating an investigational drug in the last 30 days prior to Visit 1, or who have been previously allocated a randomized code in this study.
Subjects with a history of a condition associated with poor compliance or with a history of poor compliance to therapy.
Involvement in the planning or conduct of the study.
At Visit 3, subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms since Visit 2.
Any clinically relevant abnormal findings in physical examination, laboratory values, vital signs, or ECG at the baseline visit, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study.
Planned donation of blood during the study.