Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the 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 Aug 2009
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 11, 2010
May 1, 2010
6 months
January 12, 2009
May 8, 2010
Conditions
Outcome Measures
Primary Outcomes (3)
Pulmonary function tests
Within 2 hours from first treatment, and after 2 weeks of treatment
Six minute walk test
Within 2 hours from first treatment, and after 2 weeks of treatment
Health related quality of life
Within 2 hours from first treatment, and after 2 weeks of treatment
Study Arms (2)
PulsHaler first
EXPERIMENTALPlacebo first
PLACEBO COMPARATORInterventions
treatment is for two weeks, 3 times per day
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Diagnosis established for at least 1 year;
- Post-bronchodilator FEV1/FVC \< 0.7
- Post bronchodilator FEV1 \<70% predicted
- Age: 40 years or older
- Smoking cigarettes, at least 10PY
- Patient signed the informed consent form
You may not qualify if:
- Bullous Emphysema (ruled out by recent CT)
- Hospitalization due to exacerbation of COPD within the last 3 months
- Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
- Systemic steroid treatment in the last 4 weeks
- Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- Severe cardiac disease, e.g., CHF grade 3 or higher
- Acute MI within last 3 months
- CABG within last 3 months
- Other severe systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Respinova LTDlead
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (1)
Fridlender ZG, Arish N, Laxer U, Berkman N, Leibovitz A, Fink G, Breuer R. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. COPD. 2012 Dec;9(6):603-10. doi: 10.3109/15412555.2012.748625. Epub 2012 Dec 6.
PMID: 23215916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2009
First Posted
January 13, 2009
Study Start
August 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
May 11, 2010
Record last verified: 2010-05