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Trial record 100 of 150 for:    Ipratropium OR atrovent

Berodual® Respimat® vs Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02176187
Recruitment Status : Terminated
First Posted : June 27, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Berodual® Respimat® inhaler Drug: Berodual® metered dose inhaler Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Open Label, Four Way, Cross-over Scintigraphic Evaluation of the Respimat® Inhaler vs a Metered Dose Inhaler (HFA-MDI) Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Poor MDI Technique
Study Start Date : April 2003
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: natural technique, without instructions
randomised sequence of Berodual® Respimat® and Berodual® MDI
Drug: Berodual® Respimat® inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Drug: Berodual® metered dose inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Experimental: optimal technique, with instructions
randomised sequence of Berodual® Respimat® and Berodual® MDI
Drug: Berodual® Respimat® inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg

Drug: Berodual® metered dose inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg




Primary Outcome Measures :
  1. Percentage of dose in the whole lung [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy


Secondary Outcome Measures :
  1. Percentage of dose in the central lung zone [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy

  2. Percentage of dose in the intermediate lung zone deposition [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy

  3. Percentage of dose in the peripheral lung zone deposition [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy

  4. Peripheral lung zone/central lung zone deposition ratio (lung penetration index) [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy

  5. Percentage of dose in oropharyngeal deposition [ Time Frame: immediately after dosing ]
    Deposition of aerosol via gamma scintigraphy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have a diagnosis of COPD and must meet the following spirometric criteria:

    • Patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volulme in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS)
    • Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded
  • Male or non-pregnant/non-lactating female patients aged ≥18 years
  • Patients must demonstrate poor MDI technique prior to the start of the study. Presence of any of the following will be considered poor technique:

    • Failure to co-ordinate "firing" of an MDI with inhalation
    • Too fast an inhalation rate (> 30 litres/minute (L/min))
    • Presence of "Cold Freon" effect (MDI spray hitting the back of the throat that caused the patient to stop inhaling)
  • All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
  • Current or ex-smokers with a smoking history of >10 pack years

Exclusion Criteria:

  • Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded
  • Patients with a recent history (i.e. six months or less) of myocardial infarction
  • Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
  • Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen
  • Patients with known active tuberculosis
  • Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
  • Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  • Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1
  • Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period
  • Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit
  • Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual®
  • Patients with known narrow-angle glaucoma
  • Patients who are being treated with antihistamines (H1 receptor antagonists)
  • Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
  • Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm (plus spermicide) or subdermal implants eg: Norplant®)
  • Patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse
  • Patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit
  • Radiation exposure from clinical studies, including that from the present study and diagnostic X-rays but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years. No patient whose occupational exposure is monitored will participate in the study

Precautions: As with other anticholinergic drugs, Berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02176187     History of Changes
Other Study ID Numbers: 215.1360
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Fenoterol, ipratropium drug combination
Ipratropium
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fenoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
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