Clinical trial NCT02236169: Trial to Determine the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to ATROVENT® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg ATROVENT® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in COPD patients


Eligibility criteria: Inclusion Criteria:

All patients must have a diagnosis of COPD and must meet the following spirometric criteria:

* Patients must have a stable, moderate to severe airway obstruction with an Forced Expiratory Volume in one second (FEV1) \<=65% of predicted normal and FEV1 \<=70% of Forced vital capacity (FVC)

  * 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 age 40 years 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 cigarettes (20 cigarettes) per day for a year
* Patients must be able to satisfactorily administer the medication, perform pulmonary function tests (PFTs) 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)

Exclusion Criteria:

* Patients with significant diseases other than COPD 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 with may influence the results of the study or patients ability to participate in the study
* Patients with clinically 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 be not be conducted in these patients
* Patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm3. A repeat eosinophil count will be not be conducted in these patients
* Patients with a recent (i.e., one year or less) history of myocardial infarction
* Patients with a recent history (i.e., three years or less) of cardiac failure, patients with cardiac arrhythmia requiring therapy, patients receiving any systemic beta-blockers and patients on chronic daytime oxygen therapy
* Patients with known active tuberculosis
* Patients with a history of cancer within the last 5 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 of thoracotomy for other reason should be evaluated per exclusion criterion No.1
* Patients with an upper respiratory tract infection or COPD exacerbation in the 6 weeks prior to the screening visit (Visit 1) 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 and women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
* Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in another research study
* Patients with a history of and/or active alcohol or drug abuse

Primary outcomes:
measure: Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
timeFrame: Up to 24 hours (h) after single drug administration
measure: Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state
timeFrame: 1h after drug administration
measure: Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state
timeFrame: up to 6 h after drug administration
Secondary outcomes:
measure: Area under the plasma ipratropium concentration time curve at different time points
timeFrame: Up to 23 days after first drug administration
measure: Peak plasma ipratropium concentration at different time points
timeFrame: Up to 23 days after first drug administration
measure: Trough plasma ipratropium concentration at different time points
timeFrame: Up to 23 days after first drug administration
measure: Time to peak plasma ipratropium concentrations at steady state
timeFrame: Up to 23 days after first drug administration
measure: Degree of fluctuation (DF) of the plasma ipratropium concentrations
timeFrame: Up to 23 days after first drug administration
measure: Area under the plasma ipratropium concentration time curve
timeFrame: Day 1 after first drug administration
measure: Peak plasma ipratropium concentration
timeFrame: Day 1 after first drug administration
measure: Number of patients with adverse events
timeFrame: Up to 23 days after first drug administration
measure: Changes from baseline in pulse rate and blood pressure
timeFrame: Baseline, day 23 day after first drug administration
measure: Number of patients with clinical significant findings in laboratory tests
timeFrame: Up to 23 days after first drug administration
measure: Number of patients with clinical significant findings in physical examination
timeFrame: Up to 23 days after first drug administration
measure: Number of patients with clinical significant findings in electrocardiogram (ECG)
timeFrame: Up to 23 days after first drug administration
measure: Changes from test-day baseline in pulse rate and blood pressure
timeFrame: Up to 23 days after first drug administration
Other outcomes:
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