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

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg; Drug: Ipratropium 500 µg; Drug: Salbutamol sulphate 3 mg; Drug: Salbutamol sulphate 6 mg

• Registration Number: NCT02182856
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-02
• Primary Completion: 2000-07
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ipratropium bromide/salbutamol sulphate	Ipratropium bromide 500 µg/salbutamol sulphate 3 mg	Randomised sequence of four different treatments 1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg 2. Ipratropium 500 µg 3. Salbutamol sulphate 3 mg 4. Salbutamol sulphate 6 mg
Ipratropium bromide/salbutamol sulphate	Ipratropium 500 µg	Randomised sequence of four different treatments 1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg 2. Ipratropium 500 µg 3. Salbutamol sulphate 3 mg 4. Salbutamol sulphate 6 mg
Ipratropium bromide/salbutamol sulphate	Salbutamol sulphate 3 mg	Randomised sequence of four different treatments 1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg 2. Ipratropium 500 µg 3. Salbutamol sulphate 3 mg 4. Salbutamol sulphate 6 mg
Ipratropium bromide/salbutamol sulphate	Salbutamol sulphate 6 mg	Randomised sequence of four different treatments 1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg 2. Ipratropium 500 µg 3. Salbutamol sulphate 3 mg 4. Salbutamol sulphate 6 mg

Primary Outcome Measures

Name	Time	Method
Area under the curve of arterial oxygen saturation (SaO2)	over 70 min observation period from each start of nebulisation

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume in the first second of expiration (FEV1)	up to 60 min after end of nebulisation
Forced (expiratory) vital capacity (FVC)	up to 60 min after end of nebulisation
Relaxed (expiratory) vital capacity (VC)	up to 60 min after end of nebulisation
Forced expiratory ratio (FER)	up to 60 min after end of nebulisation