Clinical trial: Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease (NCT00801307)

Eligibility criteria:
Inclusion Criteria:

          -  All subjects/patients:

               -  Willing and able to complete the requirements of this study including the
                  signature of the written informed consent,

               -  Able to complete the study in 5 working days or less,

               -  Able to perform pulmonary function tests

          -  Healthy volunteers:

               -  Never smoker or subject who stopped smoking at least 6 months before selection
                  (strictly less than 10 pack-years),

               -  Having pulmonary function tests within the normal range(according to predicted
                  values for age, sex and height as referenced in ATS/ERS 1993 standards)

          -  Patients with moderate/severe persistent asthma:

               -  Documented clinical diagnosis of moderate or severe persistent asthma (according
                  to GINA 2006 guidelines),

               -  Stable asthma in the 4 weeks prior to selection as evidenced by no change in
                  asthma medication, no treatment for asthma in an emergency,acute care setting and
                  no admission to hospital for acute asthma

        Patients with moderate / severe COPD:

          -  Aged ≥ 45 and £ 80 years old,

          -  Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006
             guidelines),

          -  With a smoking history of 10 pack-years or more,

          -  Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD
             medication, no treatment for COPD in an emergency, acute care setting and no admission
             to hospital for COPD exacerbation

        Exclusion Criteria:

          -  Obese subject/patient having a Body Mass Index (BMI) > 35,

          -  Past or present respiratory disease including being free from the common cold and
             rhinitis for at least 4 weeks before selection except asthma for asthmatic patients
             and COPD for COPD patients,

          -  Daily need for 12 hours or more of long term oxygen therapy,

          -  Pregnant or lactating woman,

          -  Lack of efficient contraception according to CPMP/ICH 286/95 note 31,

          -  Any contra-indication to perform pulmonary function tests or light cycling exercise,

          -  Clinically significant or uncontrolled pathologic conditions which may interfere with
             the study procedures,

          -  Drug abuse or psychic disorders resulting in an inability to fully understand the
             requirements of the study,

          -  Legal status which prohibits informed consent,

          -  Participation in any interventional clinical trial within 30 days prior to selection
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? Entailment