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PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187589
First Posted: August 24, 2010
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Respinova LTD
  Purpose
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Condition Intervention
COPD Device: Pulsehaler Drug: Nebulizer & Albuterol 0.5ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Resource links provided by NLM:


Further study details as provided by Respinova LTD:

Primary Outcome Measures:
  • Lung deposition [ Time Frame: 1 hour ]
    Lung deposition of the albuterol-containing aerosol

  • Pulmonary functions [ Time Frame: 1 hour ]
    Pulmonary function tests by spirometry


Secondary Outcome Measures:
  • Dyspnea [ Time Frame: 1 hour ]
    Dyspnea measured by the modified Borg scale


Estimated Enrollment: 15
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulsehaler
Fully operational Pulsehaler, with protocol enabled
Device: Pulsehaler Drug: Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer
Active Comparator: Nebulizer
Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active
Drug: Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
  • 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:

  • Pneumothorax in the past, per anamnesis.
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187589


Locations
Israel
Assaf Harofe Medical Center Nuclear Medicine Institute
Tzrifin, Israel
Sponsors and Collaborators
Respinova LTD
Investigators
Principal Investigator: Haim Golan, MD Assaf Harofe Medical Center
  More Information

Responsible Party: Yuval Avni, Respinova LTD
ClinicalTrials.gov Identifier: NCT01187589     History of Changes
Other Study ID Numbers: PLS-02
First Submitted: August 23, 2010
First Posted: August 24, 2010
Last Update Posted: September 23, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Albuterol
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