Clinical trial: Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT) (NCT00633776)

Eligibility criteria:
Inclusion Criteria:

          -  Symptomatic subjects with moderate to severe COPD

          -  Age greater than/equal to 40 years

          -  History of smoking greater than/equal to 20 pack-years of cigarettes

          -  No history of asthma (in the opinion of the investigator)

          -  No COPD exacerbations within the past 2 months requiring oral corticosteroids or
             hospitalization.

          -  No continuous oxygen therapy

          -  Subjects with a body mass index less than 15 or greater than 38

          -  Patients must be without other clinically significant illnesses or condition that
             might interfere with the study, including but not limited to uncontrolled
             hypertension, cardiovascular disease, cardiac arrhythmia, diabetes, hyperthyroidism,
             seizure disorder or any history of pheochromocytoma

          -  Be using medically acceptable birth-control measures if a female of child-bearing
             potential

          -  Not be pregnant or breastfeeding

          -  Be willing to withhold any existing short or long-acting bronchodilators for the
             appropriate time period prior to each test day (see below). Use of inhaled
             corticosteroids is not exclusionary, but will be maintained at a constant level
             throughout the study.

          -  Must be willing and able to perform spirometry, slow vital capacity, plethysmography,
             DLCO, and 6 minute walk after appropriate instruction.

          -  No known allergy or contradiction to albuterol or formoterol or prior significant
             adverse reactions to other beta agonists.

          -  No hypersensitivity to milk protein. Bloating or gas from lactose is not an exclusion.

          -  No use of beta-blockers (selective or non-selective), phenothiazines (thioridazine),
             or other drugs that may interact with formoterol or albuterol for the duration of the
             study. Washout of greater than seven half-lives of the drug prior to the study.

          -  No use of cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide,
             quinidine), or class III (e.g., amiodarone, dofetilide, ibutilide, sotalol),
             terfenadine, astemizole, mizolastine and any other drug with potential to
             significantly prolong the QT interval.

          -  No use of non-potassium sparing diuretics unless in fixed combination with potassium
             sparing diuretic.

          -  No investigational drugs within 30 days

          -  No subjects affiliated with the Division of Pulmonary, Critical Care Medicine and
             Hospitalists, David Geffen School of Medicine

          -  Informed consent

        Exclusion Criteria:

          -  Post-albuterol FEV1/FVC less than lower limit of normal (Hankinson)

          -  Post-albuterol FEV1 between 30% and 60% predicted (Hankinson)

          -  An increase in FEV1 after albuterol sulfate HFA of at least 5% and 50 ml
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction