A One-year Randomized, Double-blind, Placebo and Active-controlled Parallel Design Safety and Efficacy Comparison of COMBIVENT HFA Inhalation Aerosol to COMBIVENT (CFC) Inhalation Aerosol in Patients With COPD

Boehringer Ingelheim0 sites360 target enrollmentOctober 2000

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsCOMBIVENT HFA Placebo HFA COMBIVENT CFC Placebo CFC

DrugsCOMBIVENT HFA Placebo HFA COMBIVENT CFC Placebo CFC

Overview

Phase: Phase 3
Intervention: COMBIVENT HFA
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 360
Primary Endpoint: Area under the curve from 0 to 6 hours (AUC0-6) of forced expiratory volume in the first second (FEV1)
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state pharmacokinetics over one dosing interval following four weeks of therapy will be characterized.

Registry

clinicaltrials.gov

Start Date

October 2000

End Date

June 2001

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients must have a diagnosis of COPD
•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 technically satisfactory pulmonary function tests
•Patients must be able to be trained in the proper use of a metered dose inhalator (MDI)
•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
•Patients must be on at least one regular aerosol bronchodilator for control of their COPD symptoms and have symptoms of bronchospasm (wheeze or shortness of breath) present OR Patients must be on at least two classes of prescribed bronchodilators on a regular basis for control of their COPD symptoms for the three month period immediately preceding the screening visit.

Exclusion Criteria

•Patients with significant disease 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
•Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
•All patients with a serum aspartate amino transferase (ASAT/SGOT) \> 80 IU/L, serum alanine amino transferase (ALAT/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 be conducted in these patients.
•Patients who have a total bood eosinophil count \>= 600 mm\*\*
•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 who have undergone thoracotomy with pulmonary resection. Patients wth a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1

Arms & Interventions

COMBIVENT HFA

Intervention: COMBIVENT HFA

Placebo HFA

Intervention: Placebo HFA

COMBIVENT (CFC)

Intervention: COMBIVENT CFC

Placebo CFC

Intervention: Placebo CFC

Outcomes

Primary Outcomes

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

Time Frame: after 12 weeks

Secondary Outcomes

Peak FEV1 response(28 weeks)
Duration of therapeutic FEV1 response(28 weeks)
Peak FVC response(28 weeks)
Average FEV1 response as area under the curve from 0 - 6 hours divided by six (TAUC0-6)(28 weeks)
Peak expiratory flow rate (PEFR)(28 weeks)
Onset of therapeutic FEV1 response(28 weeks)
Number of puffs of rescue medication(28 weeks)
Time to peak FEV1 response(28 weeks)
Average forced vital capacity (FVC) response area under the curve from 0 - 6 hours divided by six (AUC0-6)(28 weeks)
Number of participants requiring test-day rescue therapy(28 weeks)
Plasma ipratropium concentration(pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours)
Renal excretion of albuterol fractions(pre-treatment, 0 - 2 hours, 2 - 8 hours)
Physician's global evaluation on an 8-point scale(28 weeks)
Daily COPD symptom scores(28 weeks)
Number and length of COPD exacerbations(28 weeks)
Average FEV1 response as area under the curve from 0 - 8 hours divided by six (TAUC0-8)(28 weeks)
Number of adverse events including paradoxical bronchoconstrictions(28 weeks)
Number of patients with clinically significant changes in pulse rate and blood pressure(28 weeks)
Plasma albuterol concentration(pre-treatment, 5, 15, 30 min; 1, 2, 4 and 8 hours)
Renal excretion of ipratropium fractions(pre-treatment, 0 - 2 hours, 2 - 8 hours)
Number of patients with clinically significant changes in laboratory tests(28 weeks)
Number of patients with abnormal findings in physical examination(28 weeks)
Number of patients with clinically significant changes in electrocardiogram(28 weeks)