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
1 other identifier
interventional
15
1 country
1
Brief Summary
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2010
CompletedFirst Posted
Study publicly available on registry
August 24, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 23, 2011
September 1, 2011
9 months
August 23, 2010
September 22, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Lung deposition
Lung deposition of the albuterol-containing aerosol
1 hour
Pulmonary functions
Pulmonary function tests by spirometry
1 hour
Secondary Outcomes (1)
Dyspnea
1 hour
Study Arms (2)
Pulsehaler
EXPERIMENTALFully operational Pulsehaler, with protocol enabled
Nebulizer
ACTIVE COMPARATORDeactivated Pulsehaler (protocol disabled), so only the nebulizer is active
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Respinova LTDlead
Study Sites (1)
Assaf Harofe Medical Center Nuclear Medicine Institute
Tzrifin, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haim Golan, MD
Assaf Harofe Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2010
First Posted
August 24, 2010
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 23, 2011
Record last verified: 2011-09