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Trial record 40 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo (AZCO)

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ClinicalTrials.gov Identifier: NCT01760304
Recruitment Status : Terminated (Sponsor decided to stop the study due to expiration of blinded placebo .)
First Posted : January 4, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bartolome Celli, Brigham and Women's Hospital

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 Pulmonary Disease (COPD)
Interventions Drug: Budesonide / Formoterol
Drug: Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Budesonide / Formoterol , Then Placebo Placebo Then Budesonide/Formoterol
Hide Arm/Group Description

This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )

Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Period Title: Overall Study
Started [1] 2 3
Completed 2 3
Not Completed 0 0
[1]
This is a double crossover study design, therefore each patient use intervention and placebo
Arm/Group Title Budesonide / Formoterol First , Then Placebo Placebo First, Then Budesonide/Formoterol Total
Hide Arm/Group Description

Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)

Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
62  (7) 70  (10) 67  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
2
  66.7%
2
  40.0%
Male
2
 100.0%
1
  33.3%
3
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
3
 100.0%
5
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Cardiac Output
Hide Description

Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.

All subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo.

Time Frame Change from Baseline and at 45 minutes after administration of study medication or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide / Formoterol Placebo
Hide Arm/Group Description:

In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).

Placebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: ml/beat
-0.1
(-1.1 to 0.8)
1.9
(1.3 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide / Formoterol
Comments a paired t-test was calculated comparing baseline measures and post intervention
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments [Not Specified]
Method 2-sided paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments a paired t-test was calculated comparing baseline measures and post intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired T-test
Comments [Not Specified]
2.Secondary Outcome
Title Lung Hyperinflation
Hide Description Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.
Time Frame Change from Baseline and after 45 minutes after administration of study medication or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide / Formoterol Placebo
Hide Arm/Group Description:

In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)

Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: Liters
0.34
(0.166 to 0.514)
-0.058
(-0.234 to 0.118)
3.Secondary Outcome
Title Evaluation of O2 Pulse
Hide Description Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention
Time Frame Change from Baseline and 45 minutes after administration of study medication or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide / Formoterol Placebo
Hide Arm/Group Description:

This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo

Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: ml/beat
-0.03
(-0.10 to 0.03)
0.17
(0.08 to 0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide / Formoterol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Budesonide / Formoterol Placebo
Hide Arm/Group Description

This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo

Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.

Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo

Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).

After 45 minutes , the above measurements will be repeated.

All-Cause Mortality
Budesonide / Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Budesonide / Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Budesonide / Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
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: Dr. Miguel Divo
Organization: Brigham and Women's Hospital
Phone: 8573070311
Responsible Party: Bartolome Celli, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01760304     History of Changes
Other Study ID Numbers: 2011-P-001576/1
D589BL00021/ISSSYMB0033 ( Other Grant/Funding Number: AstraZeneca pharmaceuticals )
First Submitted: October 23, 2012
First Posted: January 4, 2013
Results First Submitted: December 9, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017