PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

September 22, 2011 updated by: Respinova LTD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tzrifin, Israel
        • Assaf Harofe Medical Center Nuclear Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung deposition
Time Frame: 1 hour
Lung deposition of the albuterol-containing aerosol
1 hour
Pulmonary functions
Time Frame: 1 hour
Pulmonary function tests by spirometry
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 1 hour
Dyspnea measured by the modified Borg scale
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respinova LTD

Investigators

  • Principal Investigator: Haim Golan, MD, Assaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (ESTIMATE)

August 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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