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

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

  1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
  2. Ipratropium 500 µg
  3. Salbutamol sulphate 3 mg
  4. Salbutamol sulphate 6 mg
Other Names:
  • Combivent® UDVs®

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.

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

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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