A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02182674 | Completed Phase 2

• 1 other identifier: 1012.25
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA) inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h)

  0, 1, 2, 3, 4, 5 and 6 hours post drug administration

Secondary Outcomes (17)

• onset of therapeutic FEV1 response

  up to 8 hours post drug administration

• peak FEV1

  up to 8 hours post drug administration

• time to peak FEV1

  up to 8 hours post drug administration

• average of FEV1, pictured as area under the curve (AUC0-8h)

  0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration

• individual FEV1

  0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration

Study Arms (2)

Combivent HFA

EXPERIMENTAL

Drug: Placebo Combivent HFA; Drug: Combivent HFA

Combivent (CFC)

ACTIVE COMPARATOR

Drug: Combivent (CFC); Drug: Placebo Combivent (CFC)

Interventions

Placebo Combivent HFA DRUG

Combivent HFA

Combivent HFA DRUG

Combivent HFA

Combivent (CFC) DRUG

Combivent (CFC)

Placebo Combivent (CFC) DRUG

Combivent (CFC)

Eligibility Criteria

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

You may qualify if:

• All patients were to have a diagnosis of COPD and must have met the following criteria at visit 1: Patients were to have relatively stable, moderate to severe airway obstruction with a baseline forced expiratory volume in one second (FEV1) \<=65 % of predicted normal and FEV1 / forced vital capacity (FVC) \<=70 %.
• Patients must have demonstrated a \>= 015 % improvement in baseline FEV1 within one hour after the inhalation of two puffs of Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate per actuation; ex-mouthpiece dose)
• Male or female patients 40 years of age or older.
• Patients must have had a smoking history of more than ten pack-year. A pack-year is defined as the equivalent of smoking on pack of 20 cigarettes per day for a year.
• Patients must have been able to perform technical satisfactory pulmonary function test.
• Patients must have been able to be trained in the proper use of a metered dose inhalator (MDI)
• All patients must have signed an informed consent form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.

You may not qualify if:

• Patients with significant disease other than COPD were to 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 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 were to be excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these patients.
• Patients who had total blood eosinophil count \>= 600/mm³. A repeat eosinophil count was 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 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 or active alcohol or drug abuse.
• Patients with known active tuberculosis.
• Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit (Visit 1) or between the screening visit and visit 2.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients with current significant psychiatric disorder.
• Patients with regular use of daytime oxygen therapy.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol, Ipratropium Drug Combination

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)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Drug Combinations; Pharmaceutical Preparations

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: July 3, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 2000
• Primary Completion: August 1, 2001
• Last Updated: August 31, 2018

Record last verified: 2018-08