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Effects of Symbicort on the Ventilatory Kinematics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712854
Recruitment Status : Terminated (Closed by study sponsor; PI left the institution; responsible party changed to Columbia)
First Posted : October 24, 2012
Results First Posted : April 22, 2016
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Lung Disease
Interventions Drug: Budesonide
Drug: Symbicort
Enrollment 9
Recruitment Details The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Pre-assignment Details  
Arm/Group Title Active Medication or Placebo
Hide Arm/Group Description Data per arm is not available. Columbia will never have access to this data.
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Active Medication or Placebo
Hide Arm/Group Description Data per arm is not available. Columbia will never have access to this data.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 40 and 75 years Number Analyzed 9 participants
9
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Male and Female Number Analyzed 9 participants
9
[1]
Measure Description: Gender breakdown is not available. Columbia will never have access to this data.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).
Hide Description Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Arm/Group Title Active Medication or Placebo
Hide Arm/Group Description:
Data per arm is not available. Columbia will never have access to this data.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Exercise Time in Steady State Exercise
Hide Description Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
Arm/Group Title Active Medication or Placebo
Hide Arm/Group Description:
Data per arm is not available. Columbia will never have access to this data.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.
 
Arm/Group Title Active Medication or Placebo
Hide Arm/Group Description Data per arm is not available. Columbia will never have access to this data.
All-Cause Mortality
Active Medication or Placebo
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Active Medication or Placebo
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Medication or Placebo
Affected / at Risk (%)
Total   0/0 
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
Layout table for Results Point of Contact information
Name/Title: CU PRS Administrator
Organization: Columbia University
Phone: 212-342-1643
EMail: crchelp@columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01712854    
Other Study ID Numbers: AAAI1932
First Submitted: October 21, 2012
First Posted: October 24, 2012
Results First Submitted: March 23, 2016
Results First Posted: April 22, 2016
Last Update Posted: September 2, 2016