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)

NCT02236169 | Completed Phase 2

• 1 other identifier: 244.2480
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

• Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose

  Up to 24 hours (h) after single drug administration

• Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state

  1h after drug administration

• Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state

  up to 6 h after drug administration

Secondary Outcomes (13)

• Area under the plasma ipratropium concentration time curve at different time points

  Up to 23 days after first drug administration

• Peak plasma ipratropium concentration at different time points

  Up to 23 days after first drug administration

• Trough plasma ipratropium concentration at different time points

  Up to 23 days after first drug administration

• Time to peak plasma ipratropium concentrations at steady state

  Up to 23 days after first drug administration

• Degree of fluctuation (DF) of the plasma ipratropium concentrations

  Up to 23 days after first drug administration

Study Arms (2)

Ipratropium bromide

EXPERIMENTAL

Drug: Ipratropium bromide HFA-134a inhalation aerosol

ATROVENT

ACTIVE COMPARATOR

Drug: Atrovent CFC inhalation aerosol

Interventions

Ipratropium bromide HFA-134a inhalation aerosol DRUG

Ipratropium bromide

Atrovent CFC inhalation aerosol DRUG

ATROVENT

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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 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®)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 10, 2014
• Study Start: October 1, 2000
• Primary Completion: April 1, 2001
• Last Updated: September 10, 2014

Record last verified: 2014-09