Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD

Inclusion criteria

• Male and female patients with moderate to severe stable COPD:

• Patients with a diagnosis of chronic bronchitis and/or emphysema
• FEV1 <65% of predicted value without regard to prior treatment
• Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
• Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
• Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
• Patient aged ≥40 years
• Patients with a smoking history of ≥15 pack-years
• Patients must have given informed consent to participate in the trial

Exclusion criteria

• Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
• Patients with any of the following:

• untreated angle closure glaucoma
• hypertrophic obstructive cardiomyopathy
• tachyarrhythmia
• recent myocardial infarction (within six months of screening visit)
• severe organic cardiac or vascular disorder
• untreated hyperthyroidism
• 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 known to be hypersensitive to anticholinergic drugs or to β2 agonists
• Patients known to abuse drugs or alcohol
• Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
• Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
• Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
• 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
• Patients on home oxygen concentrator therapy
• Patients who have previously participated in the randomised phase of this trial