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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
History of Changes

August 23, 2010
September 22, 2011
December 2010
September 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01187589 on ClinicalTrials.gov Archive Site
Dyspnea [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Dyspnea measured by the modified Borg scale
Same as current
Not Provided
Not Provided
 
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • Device: Pulsehaler
  • Drug: Nebulizer & Albuterol 0.5ml
    Albuterol aerosolized by a nebulizer
  • Experimental: Pulsehaler
    Fully operational Pulsehaler, with protocol enabled
    Interventions:
    • Device: Pulsehaler
    • Drug: Nebulizer & Albuterol 0.5ml
  • Active Comparator: Nebulizer
    Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active
    Intervention: Drug: Nebulizer & Albuterol 0.5ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01187589
PLS-02
No
Yuval Avni, Respinova LTD
Respinova LTD
Not Provided
Principal Investigator: Haim Golan, MD Assaf Harofe Medical Center
Respinova LTD
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP