PulseHaler Drug Deposition Study in Chronic Obstructive P... | NCT01187589

Studies
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

NCT01187589

Sponsor

Respinova LTD

Status

Completed

Last Update Posted

Sep 23, 2011Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

COPD

Interventions

Pulsehaler
Nebulizer & Albuterol 0.5ml

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 23, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2011

Last Update Posted Date

Sep 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulsehaler	Experimental	Fully operational Pulsehaler, with protocol enabled	Device: Pulsehaler Drug: Nebulizer & Albuterol 0.5ml
Nebulizer	Active Comparator	Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active	Drug: Nebulizer & Albuterol 0.5ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulsehaler	Device		Pulsehaler
Nebulizer & Albuterol 0.5ml

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haim Golan, MD	Assaf Harofe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofe Medical Center Nuclear Medicine Institute		Tzrifin			Israel

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009330	Nebulizers and Vaporizers
D000420	Albuterol

Ancestor Terms

ID	Term
D004864	Equipment and Supplies
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided