Study of the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to the Market Standard, Atrovent® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease
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 stable, moderate to severe airway obstruction with an FEV 1 (forced expiratory volume in the first second) \<=65% of predicted normal and FEV1 \<=70% of FVC (Forced Vital Capacity)
* Males: Predicted normal FEV1=0.093 (height in inches) - 0.032(Age) - 1.343
* Females: Predicted normal 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 ten pack-years
Patients must be able to demonstrate an improvement in FEV1 \>=015% within one hour after inhalation of two puffs of Atrovent® inhalation aerosol (21 mcg per puff)
Patients must be able to satisfactorily administer the medication, perform pulmonary function test and maintain records during the study period as required in the protocol
All patients must sign an informed consent form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)
You may not be if
Patients with significant disease other than COPD were will be excluded. A significant 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 which may influence the results of the study or the patient's ability to participate in the study
Patients with clinical relevant 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 (SGOT) \>80 IU/L; serum glutamic pyruvic transaminase (SGPT) \>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 not to be conducted in these patients
Patients with a history of asthma, allergic rhinitis or atopy or have a blood eosinophil count above 600/mm³. A repeat eosinophil count will not to be conducted in these patients
Patients with a recent history (i.e., one year or less) of myocardial infarction
Patients with a recent history (i.e., three years or less) of heart failure, patients with any cardiac arrhythmia requiring therapy, patients receiving any systemic beta blocker and patients on chronic daytime oxygen therapy
Patients with known active tuberculosis
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
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 or a thoracotomy for other reasons be evaluated as per exclusion criterion No. 1
Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit (vist1) or during the baseline period
Patients with known hypersensitivity to anticholinergic drugs
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma
Patients who are on cromolyn sodium or nedocromil sodium
Patients who are on antihistamines
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptives, intrauterine devices, diaphragm or Norplant®)
Patients who have taken an investigational drug within one month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in other research study
Patients with a history of and/or active alcohol or drug abuse
Patients with active infectious rhinitis (common cold) as determined by history and physical
Patients with upper or lower respiratory infection at screening
Clareo Health | Study of the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to the Market Standard, Atrovent® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease
