Recruitment

Recruitment Status
Terminated

Inclusion Criteria

Male or female patients 40 years of age or older
Affiliation to the French social security system or beneficiary of such a system
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%.
...
Male or female patients 40 years of age or older
Affiliation to the French social security system or beneficiary of such a system
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

Exclusion Criteria

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

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

Male or female patients 40 years of age or older
Affiliation to the French social security system or beneficiary of such a system
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%.
...
Male or female patients 40 years of age or older
Affiliation to the French social security system or beneficiary of such a system
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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02182869
Collaborators
Not Provided
Investigators
Not Provided