PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Respinova LTD
ClinicalTrials.gov Identifier:
NCT01187589
First received: August 23, 2010
Last updated: September 22, 2011
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Lung deposition of the albuterol-containing aerosol

  • Pulmonary functions [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Pulmonary function tests by spirometry


Secondary Outcome Measures:
  • Dyspnea [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yuval Avni, Respinova LTD
ClinicalTrials.gov Identifier: NCT01187589     History of Changes
Other Study ID Numbers: PLS-02
Study First Received: August 23, 2010
Last Updated: September 22, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014