Aerosol Inhalation Treatment for Dyspnea
This study is currently recruiting participants.
Verified March 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01440764
First received: September 23, 2011
Last updated: March 14, 2013
Last verified: March 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 23, 2011 | ||||||||
| Last Updated Date | March 14, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Subject rating of Breathing Discomfort (dyspnea) [ Time Frame: repeated measurement for 2 hours from intervention ] [ Designated as safety issue: No ] Subjects will rate breathing discomfort (dyspnea) using a visual analog scale before and after intervention |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01440764 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aerosol Inhalation Treatment for Dyspnea | ||||||||
| Official Title ICMJE | Aerosol Inhalation Treatment for Dyspnea | ||||||||
| Brief Summary | The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea. |
||||||||
| Detailed Description | This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Drug: Furosemide
Subjects will inhale 80mg of furosemide aerosol over the course of 5-10 min. There will be a single administration of aerosol furosemide and either aerosol albuterol or aerosol saline in each subject, as well as an IV furosemide dose to control for systemic effects. Each intervention will occur on a separate day.
Other Name: Lasix |
||||||||
| Study Arm (s) | Experimental: Aerosol furosemide
Intervention: Drug: Furosemide |
||||||||
| Publications * | Banzett RB, Adams L, O'Donnell CR, Gilman SA, Lansing RW, Schwartzstein RM. Using Laboratory Models to Test Treatment: Morphine Reduces Dyspnea and Hypercapnic Ventilatory Response. Am J Respir Crit Care Med. 2011. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01440764 | ||||||||
| Other Study ID Numbers ICMJE | 2011-P-000027/1, R01NR012009 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Beth Israel Deaconess Medical Center | ||||||||
| Study Sponsor ICMJE | Beth Israel Deaconess Medical Center | ||||||||
| Collaborators ICMJE | National Institute of Nursing Research (NINR) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Beth Israel Deaconess Medical Center | ||||||||
| Verification Date | March 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||