Combivent® HFA-propelled Compared to CFC-propelled Metered Dose Inhaler in Patients With COPD (Chronic Obstructive Pulmonary Disease)

NCT02182869 | Terminated Phase 2

• 1 other identifier: 1012.43
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (8)

• Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals)

  Baseline, up to 8 days after last treatment day

• Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate)

  Baseline, up to 8 days after last treatment day

• Changes in intra ocular pressure (IOP)

  Baseline, up to 30 min after last drug administration

• Changes in serum potassium levels

  Baseline, up to 180 min after last drug administration

• Changes in serum glucose levels

  Baseline, up to 60 min after last drug administration

• Number of patients with clinically significant changes from baseline in clinical laboratory evaluations

  Baseline, 8 days after last treatment day

• Number of patients with adverse events including paradoxical bronchospasm

  Up to 8 days after last treatment day

• Number of patients with clinically significant changes from baseline in physical examination

  Baseline, 8 days after last treatment day

Secondary Outcomes (2)

• Change in FEV1 (forced expiratory volume in one second)

  Baseline, up to 180 min after last drug administration

• Change in FVC (forced vital capacity)

  Baseline, up to 180 min after last drug administration

Study Arms (2)

Combivent® HFA

EXPERIMENTAL

Drug: Combivent® HFA inhalation aerosol

Combivent® CFC

ACTIVE COMPARATOR

Drug: Combivent® CFC inhalation aerosol

Interventions

Combivent® HFA inhalation aerosol DRUG

Combivent® HFA

Combivent® CFC inhalation aerosol 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:

• Male or female patients 40 years of age or older
• A diagnosis of COPD as defined by American Thoracic Society (ATS) criteria. Patients must have relatively stable, moderate to severe airway obstruction with a baseline FEV 1 \<=65% of predicted normal and FEV1/FVC \>=70%.
• 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
• Able to perform technical satisfactory pulmonary function test
• Able to be trained in the proper use of a MDI
• Having signed an informed consent from prior to participation in the trial
• Affiliation to the French social security system or beneficiary of such a system

You may not qualify if:

• Significant disease other than COPD. 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
• Serum glutamic oxaloacetic transaminase (SGOT) \>80 IU/L; serum glutamic pyruvic transaminase (SGPT) \>80IU/L, bilirubin \>2.0mg/dL or creatinine \>2.0mg/dL
• Serum potassium level above or below the normal range
• Total blood eosinophil count \>=600/mm³
• Recent history (i.e., one year or less) of myocardial infarction
• Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy
• History of cancer, other than treated basal cell carcinoma, within the last five years
• History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
• History of asthma, allergic rhinitis or atopy
• History of or active alcohol or drug abuse
• Known active tuberculosis
• Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
• Known symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow-angle glaucoma
• Current significant psychiatric disorders

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2001
• Primary Completion: August 1, 2001
• Last Updated: August 31, 2018

Record last verified: 2018-08