Combivent® HFA-propelled Compared to CFC-propelled Metered Dose Inhaler in Patients With COPD (Chronic Obstructive Pulmonary Disease)
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
Inclusion Criteria
- Affiliation to the French social security system or beneficiary of such a system
- Having signed an informed consent from prior to participation in the trial
- Male or female patients 40 years of age or older
- ...
- Affiliation to the French social security system or beneficiary of such a system
- Having signed an informed consent from prior to participation in the trial
- Male or female patients 40 years of age or older
- 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 be trained in the proper use of a MDI
- 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%.
Exclusion Criteria
- 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
- 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
- ...
- 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
- 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
- Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
- Known active tuberculosis
- Patient leaving in medical or social establishments
- Use of antihistamines.
- Total blood eosinophil count >=600/mm³
- Use of cromolyn sodium or nedocromil sodium
- 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 an investigational drug within one month or six half lives prior to the screening visit
- Known narrow-angle glaucoma
- Regular use of daytime oxygen therapy
- Current significant psychiatric disorders
- History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
- Serum potassium level above or below the normal range
- History of or active alcohol or drug abuse
- 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 under guardianship
- Patient deprived of their freedom by a judicial or administrative decision
- Previous participation in this study
- History of asthma, allergic rhinitis or atopy
- History of cancer, other than treated basal cell carcinoma, within the last five years
- 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
- Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
- Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
- History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- Known symptomatic prostatic hypertrophy or bladder neck obstruction
- Patient in emergency situations
- 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
- 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
- Patient hospitalized for mental disorder without his (her) consent
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
- Affiliation to the French social security system or beneficiary of such a system
- Having signed an informed consent from prior to participation in the trial
- Male or female patients 40 years of age or older
- ...
- Affiliation to the French social security system or beneficiary of such a system
- Having signed an informed consent from prior to participation in the trial
- Male or female patients 40 years of age or older
- 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 be trained in the proper use of a MDI
- 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%.
Exclusion Criteria
- 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
- 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
- ...
- 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
- 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
- Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
- Known active tuberculosis
- Patient leaving in medical or social establishments
- Use of antihistamines.
- Total blood eosinophil count >=600/mm³
- Use of cromolyn sodium or nedocromil sodium
- 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 an investigational drug within one month or six half lives prior to the screening visit
- Known narrow-angle glaucoma
- Regular use of daytime oxygen therapy
- Current significant psychiatric disorders
- History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
- Serum potassium level above or below the normal range
- History of or active alcohol or drug abuse
- 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 under guardianship
- Patient deprived of their freedom by a judicial or administrative decision
- Previous participation in this study
- History of asthma, allergic rhinitis or atopy
- History of cancer, other than treated basal cell carcinoma, within the last five years
- 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
- Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
- Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
- History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- Known symptomatic prostatic hypertrophy or bladder neck obstruction
- Patient in emergency situations
- 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
- 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
- Patient hospitalized for mental disorder without his (her) consent
Tracking Information
- NCT #
- NCT02182869
- Collaborators
- Not Provided
- Investigators
- Not Provided