- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182856
Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
July 4, 2014 updated by: Boehringer Ingelheim
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 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ipratropium bromide/salbutamol sulphate
Randomised sequence of four different treatments
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve of arterial oxygen saturation (SaO2)
Time Frame: over 70 min observation period from each start of nebulisation
|
over 70 min observation period from each start of nebulisation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume in the first second of expiration (FEV1)
Time Frame: up to 60 min after end of nebulisation
|
up to 60 min after end of nebulisation
|
Relaxed (expiratory) vital capacity (VC)
Time Frame: up to 60 min after end of nebulisation
|
up to 60 min after end of nebulisation
|
Forced (expiratory) vital capacity (FVC)
Time Frame: up to 60 min after end of nebulisation
|
up to 60 min after end of nebulisation
|
Forced expiratory ratio (FER)
Time Frame: up to 60 min after end of nebulisation
|
up to 60 min after end of nebulisation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1998
Primary Completion (Actual)
July 1, 2000
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Bromides
- Ipratropium
Other Study ID Numbers
- 1012.39
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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