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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg (Drug); Ipratropium 500 µg (Drug); Salbutamol sulphate 3 mg (Drug); Salbutamol sulphate 6 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

Official title: A Randomised, Double-blind, Active-controlled, Within-patient Trial Comparing the Effect of Single Doses of Nebulised Ipratropium 500g, Salbutamol Sulphate 3mg, Salbutamol 6mg and the Combination Therapy Salbutamol Sulphate 3 mg Plus Ipratropium 500g on Arterial Oxygen Saturation in Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Area under the curve of arterial oxygen saturation (SaO2)

Secondary outcome:

Forced expiratory volume in the first second of expiration (FEV1)

Relaxed (expiratory) vital capacity (VC)

Forced (expiratory) vital capacity (FVC)

Forced expiratory ratio (FER)

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 1998
Last updated: July 4, 2014

Page last updated: August 23, 2015

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