Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease

NCT02177344 | Completed Phase 3

• 1 other identifier: 244.2484
• Study Type: interventional
• Target: 646
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD). The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1)

  up to day 169

Secondary Outcomes (16)

• Peak FEV1 post treatment

  up to day 169

• Onset of therapeutic FEV1 response

  up to day 169

• Duration of therapeutic FEV1 response

  up to day 169

• Time to peak FEV1 response

  up to day 169

• Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response

  up to day 169

Study Arms (4)

Low dose of ipratropium bromide

EXPERIMENTAL

Drug: Low dose of Ipratropium bromide

High dose of Ipratopium bromide

EXPERIMENTAL

Drug: High dose of Ipratropium bromide

Atrovent

ACTIVE COMPARATOR

Drug: Atrovent

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of Ipratropium bromide DRUG

One puff, 4 times daily by oral inhalation

Low dose of ipratropium bromide

High dose of Ipratropium bromide DRUG

One puff, 4 times daily by oral inhalation

High dose of Ipratopium bromide

Atrovent DRUG

Two puffs, 4 times daily by oral inhalation

Atrovent

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 relatively stable, moderate to severe airway obstruction with a FEV1 =\< 65% of predicted normal and FEV1 =\< 70% of FVC
• Male or female patients 40 years of age or older
• Patients must have a smoking history of more than ten packs-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 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
• All patients must sign an Informed Consent Form prior to participation in the trial i.e., at least 24 hours prior to screening (Visit 1)

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 which may influence the results of the study or the patient's ability to participate in the study
• All patients with a serum glutamate oxaloacetate transaminase \> 80 U/L, serum glutamate pyruvate transaminase \> 80 U/L, bilirubin \> 34.2 µmol/L or creatinine \> 176.8 µmol/L will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
• Patients who have a blood eosinophil count \>= 0.6 GI/L. A repeat eosinophil count will not 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 or patients with any cardiac arrhythmia requiring drug therapy
• Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
• 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 six weeks prior to the Screening Visit (Visit 1) or during the baseline period
• Patients with known symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
• Patients with known narrow-angle glaucoma, or raised intra-ocular pressure
• Patients with current significant psychiatric disorders
• Patients with regular use of daytime oxygen therapy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: August 1, 1998
• Primary Completion: October 1, 1999
• Last Updated: July 17, 2014

Record last verified: 2014-06