Comparison of Safety and Efficacy of COMBIVENT HFA to COMBIVENT (CFC) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02194205 | Terminated Phase 3

• 1 other identifier: 1012.11
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

  after 12 weeks

Secondary Outcomes (23)

• Peak FEV1 response

  28 weeks

• Onset of therapeutic FEV1 response

  28 weeks

• Duration of therapeutic FEV1 response

  28 weeks

• Time to peak FEV1 response

  28 weeks

• Average FEV1 response as area under the curve from 0 - 6 hours divided by six (TAUC0-6)

  28 weeks

Study Arms (4)

COMBIVENT HFA

EXPERIMENTAL

Drug: COMBIVENT HFA

Placebo HFA

PLACEBO COMPARATOR

Drug: Placebo HFA

COMBIVENT (CFC)

ACTIVE COMPARATOR

Drug: COMBIVENT CFC

Placebo CFC

PLACEBO COMPARATOR

Drug: Placebo CFC

Interventions

COMBIVENT HFA DRUG

COMBIVENT HFA

Placebo HFA DRUG

Placebo HFA

COMBIVENT CFC DRUG

COMBIVENT (CFC)

Placebo CFC DRUG

Placebo 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 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.

You may not qualify if:

• 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
• 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\*\*3. 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 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 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 with regular use of daytime oxygen therapy

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

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: October 1, 2000
• Primary Completion: June 1, 2001
• Last Updated: July 18, 2014

Record last verified: 2014-07