Trial Outcomes & Findings for Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus) (NCT NCT00915538)
NCT ID: NCT00915538
Last Updated: 2020-08-13
Results Overview
The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
Results posted on
2020-08-13
Participant Flow
Participant milestones
| Measure |
Conventional First
This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber
|
Spacer First
This arm will receive pMDI and Valved holding chamber on fist day. On anther day will receive pMDI in usual fashion. Pulmonary functions wil be measured over 12 hours
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
Baseline characteristics by cohort
| Measure |
Conventional First
n=8 Participants
This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber
|
Spacer First
n=8 Participants
This arm will receive pMDI and Valved holding chamber on fist day. On anther day will receive pMDI in usual fashion. Pulmonary functions wil be measured over 12 hours
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 7 • n=5 Participants
|
36 years
STANDARD_DEVIATION 7 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.
Outcome measures
| Measure |
Group 1
n=16 Participants
The intervention in this group will inhalation from the pMDI containing budesonide/formoterol pMDI 160/4,5 2 inhalations as recommended in product PI (FDA approved product information)without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.
pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.
Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours.
|
Group 2
n=16 Participants
The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device (aerochamber plus)which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..
pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.
Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours.
|
|---|---|---|
|
The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.
|
2.77 Liters X hours
Interval 0.0 to 720.0
|
2.79 Liters X hours
Interval 0.0 to 720.0
|
SECONDARY outcome
Timeframe: 0,5,10,15,30,60,120,240,480,720 minutesPopulation: This is a cross over design. 2 cohorts of 8 subjects will be tested in a cross over design, so that 16 measurements will be made for each intervention. This should give power of 0.8 for non inferiority equivalence study.
The ratio of the volumes in liters of FEV-1 to Forced vital capacity (FVC). This is reported as percent for each time point., Each time point will be compared.for the two interventions. This expressed as a percentage.
Outcome measures
| Measure |
Group 1
n=16 Participants
The intervention in this group will inhalation from the pMDI containing budesonide/formoterol pMDI 160/4,5 2 inhalations as recommended in product PI (FDA approved product information)without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.
pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.
Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours.
|
Group 2
n=16 Participants
The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device (aerochamber plus)which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..
pMDI budesonide/formotrol 160/4.5 is in group 1: The subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours.
Symbicort 160/4.5 plus Aerochamber Plus icluded in group 2: Symbicort 160/4.5 will be administered through a valved holding chamber, Pulmonary functions will be measured over 12 hours.
|
|---|---|---|
|
FEV-1/FVC
0 time
|
76.13 percentage of fev1/fvc
Standard Deviation 11.7
|
75.58 percentage of fev1/fvc
Standard Deviation 12.5
|
|
FEV-1/FVC
5 minutes
|
79.08 percentage of fev1/fvc
Standard Deviation 12.07
|
79.91 percentage of fev1/fvc
Standard Deviation 14.33
|
|
FEV-1/FVC
10 minutes
|
78.55 percentage of fev1/fvc
Standard Deviation 13.53
|
81.16 percentage of fev1/fvc
Standard Deviation 15.08
|
|
FEV-1/FVC
15 minutes
|
79.08 percentage of fev1/fvc
Standard Deviation 10.80
|
80.29 percentage of fev1/fvc
Standard Deviation 13.13
|
|
FEV-1/FVC
30 minutes
|
80.17 percentage of fev1/fvc
Standard Deviation 14.32
|
80.55 percentage of fev1/fvc
Standard Deviation 15.11
|
|
FEV-1/FVC
60 minutes
|
78.05 percentage of fev1/fvc
Standard Deviation 15.30
|
81.63 percentage of fev1/fvc
Standard Deviation 14.63
|
|
FEV-1/FVC
120 minutes
|
80.94 percentage of fev1/fvc
Standard Deviation 13.95
|
81.40 percentage of fev1/fvc
Standard Deviation 15.97
|
|
FEV-1/FVC
240 minutes
|
81.56 percentage of fev1/fvc
Standard Deviation 14.30
|
82.42 percentage of fev1/fvc
Standard Deviation 13.75
|
|
FEV-1/FVC
480 minutes
|
79.95 percentage of fev1/fvc
Standard Deviation 14.43
|
80.56 percentage of fev1/fvc
Standard Deviation 13.94
|
|
FEV-1/FVC
720 minutes
|
79.93 percentage of fev1/fvc
Standard Deviation 12.54
|
80.33 percentage of fev1/fvc
Standard Deviation 13.36
|
Adverse Events
Conventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Spacer
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place