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Aerosol Inhalation Treatment for Dyspnea

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ClinicalTrials.gov Identifier: NCT01440764
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Robert Banzett, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions: Healthy
Dyspnea
Interventions: Drug: Furosemide
Drug: Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a crossover study of a total of 24 people.

Reporting Groups
  Description
F(40), Then Saline, Then IV.F

On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

IV.F, Then F(40), Then Saline

On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

Saline, Then F(40), Then IV.F

On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

Saline, Then F(80), Then IV.F

On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

F(80), Then Saline, Then Saline

On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

Saline, Then F(80), Then Saline

On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

Saline, Then Saline, Then F(80)

On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.


Participant Flow for 3 periods

Period 1:   Test Day 1
    F(40), Then Saline, Then IV.F   IV.F, Then F(40), Then Saline   Saline, Then F(40), Then IV.F   Saline, Then F(80), Then IV.F   F(80), Then Saline, Then Saline   Saline, Then F(80), Then Saline   Saline, Then Saline, Then F(80)
STARTED   4   2   6   1   3   5   3 
COMPLETED   4   2   6   1   3   5   3 
NOT COMPLETED   0   0   0   0   0   0   0 

Period 2:   Test Day 2
    F(40), Then Saline, Then IV.F   IV.F, Then F(40), Then Saline   Saline, Then F(40), Then IV.F   Saline, Then F(80), Then IV.F   F(80), Then Saline, Then Saline   Saline, Then F(80), Then Saline   Saline, Then Saline, Then F(80)
STARTED   3 [1]   2   6   1   3   5   3 
COMPLETED   3   2   6   1   3   5   3 
NOT COMPLETED   0   0   0   0   0   0   0 
[1] Following Test Day 1, 1 subject withdrew from the study before beginning Test Day 2.

Period 3:   Test Day 3
    F(40), Then Saline, Then IV.F   IV.F, Then F(40), Then Saline   Saline, Then F(40), Then IV.F   Saline, Then F(80), Then IV.F   F(80), Then Saline, Then Saline   Saline, Then F(80), Then Saline   Saline, Then Saline, Then F(80)
STARTED   3   2   6   1   3   5   3 
COMPLETED   3   2   6   1   3   5   3 
NOT COMPLETED   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
F(40) Participants Participants who consented to participate in the study and receive the Aerosol Furosemide (40mg/4ml solution of Saline), Aerosol Saline (4ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
F(80) Participants Participants who consented to participate in the study and receive the Aerosol Furosemide (80mg/8ml solution of Saline) and two Aerosol Saline (8ml) Interventions in any sequence or receive the Aerosol Furosemide (80mg/8ml solution of Saline), Aerosol Saline (8ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
Total Total of all reporting groups

Baseline Measures
   F(40) Participants   F(80) Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      1   8.3%      1   4.2% 
Between 18 and 65 years      12 100.0%      11  91.7%      23  95.8% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.25  (12.65)   23.58  (4.42)   27.42  (10.06) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  25.0%      10  83.3%      13  54.2% 
Male      9  75.0%      2  16.7%      11  45.8% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Subject Rating of Breathing Discomfort (Dyspnea)   [ Time Frame: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively. ]

2.  Secondary:   Multidimensional Dyspnea Profile   [ Time Frame: Measured before intervention ]

3.  Secondary:   Urine Output   [ Time Frame: Cumulative urine output 1 hour after intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Banzett, PhD
Organization: Beth Israel Deaconess Medical Center
phone: (617)667-0572
e-mail: rbanzett@bidmc.harvard.edu


Publications:

Responsible Party: Robert Banzett, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01440764     History of Changes
Other Study ID Numbers: 2011-P-000027/1
R01NR012009 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2011
First Posted: September 27, 2011
Results First Submitted: April 11, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017