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

NCT02182856 | Completed Phase 4

• 1 other identifier: 1012.39
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Area under the curve of arterial oxygen saturation (SaO2)

  over 70 min observation period from each start of nebulisation

Secondary Outcomes (4)

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

  up to 60 min after end of nebulisation

• Relaxed (expiratory) vital capacity (VC)

  up to 60 min after end of nebulisation

• Forced (expiratory) vital capacity (FVC)

  up to 60 min after end of nebulisation

• Forced expiratory ratio (FER)

  up to 60 min after end of nebulisation

Study Arms (1)

Ipratropium bromide/salbutamol sulphate

EXPERIMENTAL

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

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

Interventions

Ipratropium bromide 500 µg/salbutamol sulphate 3 mg DRUG

Also known as: Combivent® UDVs®

Ipratropium bromide/salbutamol sulphate

Ipratropium 500 µg DRUG

Ipratropium bromide/salbutamol sulphate

Salbutamol sulphate 3 mg DRUG

Ipratropium bromide/salbutamol sulphate

Salbutamol sulphate 6 mg DRUG

Ipratropium bromide/salbutamol sulphate

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: February 1, 1998
• Primary Completion: July 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07