Back to resultsAssessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PulseHaler treatment
CPAP treatment (through a deactivated version of PulsHaler)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PulsHaler first
Placebo first
Arm Description
Outcomes
Primary Outcome Measures
Pulmonary function tests
Six minute walk test
Health related quality of life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00821418
Brief Title
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Respinova LTD
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PulsHaler first
Arm Type
Experimental
Arm Title
Placebo first
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
PulseHaler treatment
Intervention Description
treatment is for two weeks, 3 times per day
Intervention Type
Device
Intervention Name(s)
CPAP treatment (through a deactivated version of PulsHaler)
Intervention Description
treatment is for two weeks, 3 times per day
Primary Outcome Measure Information:
Title
Pulmonary function tests
Time Frame
Within 2 hours from first treatment, and after 2 weeks of treatment
Title
Six minute walk test
Time Frame
Within 2 hours from first treatment, and after 2 weeks of treatment
Title
Health related quality of life
Time Frame
Within 2 hours from first treatment, and after 2 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
23215916
Citation
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.
Results Reference
derived
Learn more about this trial
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
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