Recruitment

Recruitment Status
Terminated

Inclusion Criteria

Able to perform technical satisfactory pulmonary function test
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%.
Having signed an informed consent from prior to participation in the trial
...
Able to perform technical satisfactory pulmonary function test
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%.
Having signed an informed consent from prior to participation in the trial
Male or female patients 40 years of age or older
Able to be trained in the proper use of a MDI
Affiliation to the French social security system or beneficiary of such a system
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

Exclusion Criteria

Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
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
...
Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
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
Use of oral beta-adrenergics or long-acting beta-adrenergics such as salmeterol (Serevent®) and formoterol in the two weeks prior to the screening visit or between the screening visit and visit 2
Use of cromolyn sodium or nedocromil sodium
History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
Known active tuberculosis
Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
Use of antihistamines.
Total blood eosinophil count >=600/mm³
Serum potassium level above or below the normal range
Current significant psychiatric disorders
History of or active alcohol or drug abuse
Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy
Recent history (i.e., one year or less) of myocardial infarction
Regular use of daytime oxygen therapy
Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
Use of beta-blocker medications, mono-amine oxidase inhibitors or tricyclic antidepressants
History of asthma, allergic rhinitis or atopy
Use of an investigational drug within one month or six half lives prior to the screening visit
History of cancer, other than treated basal cell carcinoma, within the last five years
Known symptomatic prostatic hypertrophy or bladder neck obstruction
Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
Patient in emergency situations
Patient under guardianship
Previous participation in this study
Patient hospitalized for mental disorder without his (her) consent
Patient deprived of their freedom by a judicial or administrative decision
Patient leaving in medical or social establishments
Known narrow-angle glaucoma

Summary

Conditions
Pulmonary Disease, Chronic Obstructive
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 125 years
Gender
Both males and females

Inclusion Criteria

Able to perform technical satisfactory pulmonary function test
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%.
Having signed an informed consent from prior to participation in the trial
...
Able to perform technical satisfactory pulmonary function test
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%.
Having signed an informed consent from prior to participation in the trial
Male or female patients 40 years of age or older
Able to be trained in the proper use of a MDI
Affiliation to the French social security system or beneficiary of such a system
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

Exclusion Criteria

Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
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
...
Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
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
Use of oral beta-adrenergics or long-acting beta-adrenergics such as salmeterol (Serevent®) and formoterol in the two weeks prior to the screening visit or between the screening visit and visit 2
Use of cromolyn sodium or nedocromil sodium
History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
Known active tuberculosis
Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
Use of antihistamines.
Total blood eosinophil count >=600/mm³
Serum potassium level above or below the normal range
Current significant psychiatric disorders
History of or active alcohol or drug abuse
Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy
Recent history (i.e., one year or less) of myocardial infarction
Regular use of daytime oxygen therapy
Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
Use of beta-blocker medications, mono-amine oxidase inhibitors or tricyclic antidepressants
History of asthma, allergic rhinitis or atopy
Use of an investigational drug within one month or six half lives prior to the screening visit
History of cancer, other than treated basal cell carcinoma, within the last five years
Known symptomatic prostatic hypertrophy or bladder neck obstruction
Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
Patient in emergency situations
Patient under guardianship
Previous participation in this study
Patient hospitalized for mental disorder without his (her) consent
Patient deprived of their freedom by a judicial or administrative decision
Patient leaving in medical or social establishments
Known narrow-angle glaucoma

Tracking Information

NCT #
NCT02182869
Collaborators
Not Provided
Investigators
Not Provided