Trial Outcomes & Findings for Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo (NCT NCT01760304)

Last Updated: 2017-06-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Change from Baseline and at 45 minutes after administration of study medication or placebo

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Budesonide / Formoterol , Then Placebo 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.	Placebo Then Budesonide/Formoterol 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.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Budesonide / Formoterol First , Then Placebo n=2 Participants 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.	Placebo First, Then Budesonide/Formoterol n=3 Participants 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 n=5 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 7 • n=5 Participants	70 years STANDARD_DEVIATION 10 • n=7 Participants	67 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline and at 45 minutes after administration of study medication or placebo

Outcome measures

Outcome measures
Measure	Budesonide / Formoterol n=5 Participants 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.	Placebo n=5 Participants 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.
Cardiac Output	-0.1 ml/beat Interval -1.1 to 0.8	1.9 ml/beat Interval 1.3 to 2.5

SECONDARY outcome

Timeframe: Change from Baseline and after 45 minutes after administration of study medication or placebo

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.

Outcome measures

Outcome measures
Measure	Budesonide / Formoterol n=5 Participants 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.	Placebo n=5 Participants 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.
Lung Hyperinflation	0.34 Liters Interval 0.166 to 0.514	-0.058 Liters Interval -0.234 to 0.118

SECONDARY outcome

Timeframe: Change from Baseline and 45 minutes after administration of study medication or placebo

Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention

Outcome measures

Outcome measures
Measure	Budesonide / Formoterol n=5 Participants 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.	Placebo n=5 Participants 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.
Evaluation of O2 Pulse	-0.03 ml/beat Interval -0.1 to 0.03	0.17 ml/beat Interval 0.08 to 0.26

Adverse Events

Budesonide / Formoterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miguel Divo

Brigham and Women's Hospital

Phone: 8573070311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place