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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014