Back to resultsIpratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
Ipratropium 500 µg
Salbutamol sulphate 3 mg
Salbutamol sulphate 6 mg
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ipratropium bromide/salbutamol sulphate
Arm Description
Randomised sequence of four different treatments Ipratropium bromide 500 µg/salbutamol sulphate 3 mg Ipratropium 500 µg Salbutamol sulphate 3 mg Salbutamol sulphate 6 mg
Outcomes
Primary Outcome Measures
Area under the curve of arterial oxygen saturation (SaO2)
Secondary Outcome Measures
Forced expiratory volume in the first second of expiration (FEV1)
Relaxed (expiratory) vital capacity (VC)
Forced (expiratory) vital capacity (FVC)
Forced expiratory ratio (FER)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182856
Brief Title
Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
Official Title
A Randomised, Double-blind, Active-controlled, Within-patient Trial Comparing the Effect of Single Doses of Nebulised Ipratropium 500µg, Salbutamol Sulphate 3mg, Salbutamol 6mg and the Combination Therapy Salbutamol Sulphate 3 mg Plus Ipratropium 500µg on Arterial Oxygen Saturation in Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ipratropium bromide/salbutamol sulphate
Arm Type
Experimental
Arm Description
Randomised sequence of four different treatments
Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
Ipratropium 500 µg
Salbutamol sulphate 3 mg
Salbutamol sulphate 6 mg
Intervention Type
Drug
Intervention Name(s)
Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
Other Intervention Name(s)
Combivent® UDVs®
Intervention Type
Drug
Intervention Name(s)
Ipratropium 500 µg
Intervention Type
Drug
Intervention Name(s)
Salbutamol sulphate 3 mg
Intervention Type
Drug
Intervention Name(s)
Salbutamol sulphate 6 mg
Primary Outcome Measure Information:
Title
Area under the curve of arterial oxygen saturation (SaO2)
Time Frame
over 70 min observation period from each start of nebulisation
Secondary Outcome Measure Information:
Title
Forced expiratory volume in the first second of expiration (FEV1)
Time Frame
up to 60 min after end of nebulisation
Title
Relaxed (expiratory) vital capacity (VC)
Time Frame
up to 60 min after end of nebulisation
Title
Forced (expiratory) vital capacity (FVC)
Time Frame
up to 60 min after end of nebulisation
Title
Forced expiratory ratio (FER)
Time Frame
up to 60 min after end of nebulisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.39_U01-1283.pdf
Description
Related Info
Learn more about this trial
Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
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