Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease

NCT02177253 | Completed Phase 3

• 1 other identifier: 1012.46
• Study Type: interventional
• Target: 1,118
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to compare the long-term (12-week) bronchodilator efficacy and safety of ipratropium bromide / salbutamol combination administered by the Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An additional objective was to show the superiority of Combivent Respimat as compared to ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing interval following four weeks of therapy were also characterized.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• FEV1 TAUC0-6 (Total area under the FEV1 (forced expiratory volume in one second) curve from 0 to 6 hours divided by six)

  Day 85

Secondary Outcomes (25)

• FEV1 TAUC0-6

  Days 1, 29 and 57

• FEV1 TAUC0-8

  Days 1, 29, 57 and 85

• Peak FEV1 post treatment over two hours

  Days 1, 29, 57 and 85

• Change from baseline in Peak FEV1 response

  Days 1, 29, 57 and 85

• Area under the FEV1 curve from 0 to 6 hours above test-day baseline divided by six for normalization (AUC0-6)

  Days 1, 29, 57 and 85

Study Arms (5)

Ipratropium bromide / Salbutamol Inhalation solution

EXPERIMENTAL

Drug: Ipratropium bromide / Salbutamol

Placebo Inhalation solution

PLACEBO COMPARATOR

Drug: Placebo Inhalation solution

Ipratropium bromide Inhalation solution

EXPERIMENTAL

Drug: Ipratropium bromide

COMBIVENT Inhalation Aerosol (ipratropium bromide/salbutamol)

ACTIVE COMPARATOR

Drug: COMBIVENT Inhalation Aerosol

Placebo Inhalation Aerosol

PLACEBO COMPARATOR

Drug: Placebo Inhalation Aerosol

Interventions

Ipratropium bromide / Salbutamol DRUG

Ipratropium bromide / Salbutamol Inhalation solution

Placebo Inhalation solution DRUG

Placebo Inhalation solution

Ipratropium bromide DRUG

Ipratropium bromide Inhalation solution

COMBIVENT Inhalation Aerosol DRUG

COMBIVENT Inhalation Aerosol (ipratropium bromide/salbutamol)

Placebo Inhalation Aerosol DRUG

Placebo Inhalation Aerosol

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 the following spirometric criteria:
• Visit 1 (Screening) and Visit 2: Patients must have relatively stable, moderate to severe airway obstruction with an 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 pack-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 MDI (metered dose inhaler) and the Respimat® inhaler
• All patients must sign an Informed Consent Form prior to participation in the trial

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 SGOT (serum glutamic oxaloacetic transaminase) \>80 IU/L, SGPT (serum glutamic pyruvic transaminase) \>80 IU/L, bilirubin \>2.0 mg/dL or creatinine \>2.0 mg/dL will be excluded regardless of the clinical condition
• Patients who have a total blood eosinophil count ≥600/mm3
• 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 5 years
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
• Patients with a history of asthma or allergic rhinitis
• Patients with a history of and/or active alcohol or drug abuse
• Patients with known active tuberculosis
• Patients with an upper or lower 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 symptomatic prostatic hypertrophy or bladder neck obstruction
• Patients with known narrow-angle glaucoma
• Patients with current significant psychiatric disorders
• Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Albuterol

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; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

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 20, 2014
• First Posted: June 27, 2014
• Study Start: October 1, 2002
• Primary Completion: March 1, 2004
• Last Updated: June 27, 2014

Record last verified: 2014-06