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

NCT02260011 | Completed Phase 2

• 1 other identifier: 244.2498
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)

  After each drug administration

Secondary Outcomes (9)

• Changes in peak FEV1 response

  Baseline and after each drug administration

• Onset of therapeutic FEV1 response

  After each drug administration

• Duration of therapeutic FEV1 response

  After each drug administration

• Time to peak FEV1 response

  After each drug administration

• Forced Vital Capacity (FVC) AUC0-6

  After each drug administration

Study Arms (5)

Ipratropium bromide HFA-134a low

EXPERIMENTAL

Drug: Ipratropium bromide HFA-134a inhalation aerosol

Ipratropium bromide HFA-134a high

EXPERIMENTAL

Drug: Ipratropium bromide HFA-134a inhalation aerosol

Atrovent® CFC low

ACTIVE COMPARATOR

Drug: Atrovent® CFC inhalation aerosol

Atrovent® CFC high

ACTIVE COMPARATOR

Drug: Atrovent® CFC inhalation aerosol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ipratropium bromide HFA-134a inhalation aerosol DRUG

Ipratropium bromide HFA-134a high; Ipratropium bromide HFA-134a low

Atrovent® CFC inhalation aerosol DRUG

Atrovent® CFC high; Atrovent® CFC low

Placebo DRUG

Placebo

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 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 qualify 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
• 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 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®)

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2000
• Primary Completion: February 1, 2001
• Last Updated: October 9, 2014

Record last verified: 2014-10