Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Patients with a smoking history of ≥15 pack-years
- Patients with a diagnosis of chronic bronchitis and/or emphysema
- Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- ...
- Patients with a smoking history of ≥15 pack-years
- Patients with a diagnosis of chronic bronchitis and/or emphysema
- Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
- Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
- Patient aged ≥40 years
- Patients must have given informed consent to participate in the trial
- FEV1 <65% of predicted value without regard to prior treatment
Exclusion Criteria
- Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- untreated hyperthyroidism
- tachyarrhythmia
- ...
- Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- untreated hyperthyroidism
- tachyarrhythmia
- Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
- Patients who have previously participated in the randomised phase of this trial
- diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
- Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
- Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
- Patients known to abuse drugs or alcohol
- Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
- Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
- recent myocardial infarction (within six months of screening visit)
- Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
- hypertrophic obstructive cardiomyopathy
- severe organic cardiac or vascular disorder
- untreated angle closure glaucoma
- Patients on home oxygen concentrator therapy
Summary
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Patients with a smoking history of ≥15 pack-years
- Patients with a diagnosis of chronic bronchitis and/or emphysema
- Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- ...
- Patients with a smoking history of ≥15 pack-years
- Patients with a diagnosis of chronic bronchitis and/or emphysema
- Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
- Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
- Patient aged ≥40 years
- Patients must have given informed consent to participate in the trial
- FEV1 <65% of predicted value without regard to prior treatment
Exclusion Criteria
- Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- untreated hyperthyroidism
- tachyarrhythmia
- ...
- Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- untreated hyperthyroidism
- tachyarrhythmia
- Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
- Patients who have previously participated in the randomised phase of this trial
- diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
- Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
- Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
- Patients known to abuse drugs or alcohol
- Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
- Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
- recent myocardial infarction (within six months of screening visit)
- Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
- hypertrophic obstructive cardiomyopathy
- severe organic cardiac or vascular disorder
- untreated angle closure glaucoma
- Patients on home oxygen concentrator therapy
Tracking Information
- NCT #
- NCT02182856
- Collaborators
- Not Provided
- Investigators
- Not Provided