Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \<=65% of predicted normal and FEV1 \<=70% of forced vital capacity (FVC). Predicted normal value will be calculated according to Morris
* Males: FEV1 = 0.093 (Height in inches)-0.032 (age)-1.343
* Females: FEV1 = 0.085 (Height. in inches)-0.025(age)-1.692
Male or female patients 40 years of age or older
Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol
Patients must be able to be trained in the proper use of an inhalation aerosol and the RESPIMAT™ device
Patients must have a baseline electrocardiogram (ECG) with no clinical relevant arrhythmias or conduction system disease (e.g. right or left bundle branch block, second degree AV block or higher)
Patients must have an oxygen saturation of \>=90% for \>=92% of the recording time on overnight oximetry
All patients must sign an Informed Consent Form prior to participation in the trial (i.e., at least 24 hours (h) prior to the screening visit (Visit 1))
You may not be if
Patients with clinically relevant diseases other than COPD will be excluded. A clinically relevant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease with may influence the results of the study or patient's ability to participate in the study
Patients with a recent history (i.e. one year or less) of myocardial infarction
Patients with a recent history (i.e. one year or less) of heart failure or patients with any past history or active cardiac arrhythmia requiring drug therapy
Patients who have a pacemaker
Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded
All patients with serum glutamic oxaloacetic transaminase / Aspartate aminotransferase (SGOT/AST) \>80 IU/L, serum glutamic pyruvic transaminase / Alanine transaminase (SGPT/ALT) \>80 IU/L, bilirubin \>2.0 mg/dl, or creatinine \>2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects
Patients who have a blood eosinophil count \>=600/mm3. A Repeat eosinophil count will be not be conducted in these patients
Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason should be evaluated per exclusion criterion No. 1
Patients with a history of asthma, allergic rhinitis or atopy
Patients with a history of and/or active alcohol or drug abuse
Patients with known active tuberculosis
Patients with an upper respiratory tract infection or COPD exacerbation in the past 6 weeks prior to the screening visit (Visit 1) or during the baseline period
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma
Patients with current significant psychiatric disorders
Patients with regular use of daytime oxygen therapy
Patients who are being treated with cromolyn sodium or nedocromil sodium
Patients who are being treated with antihistamines
Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients who are being treated with beta-blocker medication
Patients who have had changes in their therapeutic plan within the last six weeks prior to the screening visit (visit 1)
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
Patients with known hypersensitivity to ant cholinergic drugs or any other components of the ATROVENT® RESPIMAT™ solution including bacteriostatic agent benzalkonium chlorid (BAC) and edetic acid (EDTA)
Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) prior to the screening visit (visit1)
Previous participation in this study
Clareo Health | Study to Assess the Safety of Ipratropium Bromide, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
