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Trial record 19 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02182856
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg Drug: Ipratropium 500 µg Drug: Salbutamol sulphate 3 mg Drug: Salbutamol sulphate 6 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 1998
Actual Primary Completion Date : July 2000


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
Drug: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
Other Name: Combivent® UDVs®

Drug: Ipratropium 500 µg
Drug: Salbutamol sulphate 3 mg
Drug: Salbutamol sulphate 6 mg



Primary Outcome Measures :
  1. Area under the curve of arterial oxygen saturation (SaO2) [ Time Frame: over 70 min observation period from each start of nebulisation ]

Secondary Outcome Measures :
  1. Forced expiratory volume in the first second of expiration (FEV1) [ Time Frame: up to 60 min after end of nebulisation ]
  2. Relaxed (expiratory) vital capacity (VC) [ Time Frame: up to 60 min after end of nebulisation ]
  3. Forced (expiratory) vital capacity (FVC) [ Time Frame: up to 60 min after end of nebulisation ]
  4. Forced expiratory ratio (FER) [ Time Frame: up to 60 min after end of nebulisation ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182856     History of Changes
Other Study ID Numbers: 1012.39
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bromides
Albuterol
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents