PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
NCT ID: NCT01187589
Last Updated: 2011-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2010-12-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Pulsehaler
Fully operational Pulsehaler, with protocol enabled
Pulsehaler
Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer
Nebulizer
Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active
Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer
Interventions
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Pulsehaler
Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer
Eligibility Criteria
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Inclusion Criteria
* Post-bronchodilator FEV1/FVC \< 0.7
* Post-bronchodilator FEV1 in the range 30% - 70% predicted
* Age: 40 years or older
* Patient signed the informed consent form
Exclusion Criteria
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
* Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
* Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
* Other severe systemic disease
* Non-cooperative or non-compliant patient
40 Years
85 Years
ALL
No
Sponsors
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Respinova LTD
INDUSTRY
Responsible Party
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Respinova LTD
Principal Investigators
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Haim Golan, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofe Medical Center
Locations
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Assaf Harofe Medical Center Nuclear Medicine Institute
Tzrifin, , Israel
Countries
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Other Identifiers
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PLS-02
Identifier Type: -
Identifier Source: org_study_id