Asthma
Conditions
Keywords
Asthma, Formoterol, Long Acting Beta Adrenergic Bronchodilator, Symbicort, Aerochamber
Brief summary
This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.
Detailed description
Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.
Interventions
DRUGpMDI budesonide/formotrol 160/4.5 is in group 1
The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.
DEVICESymbicort 160/4.5 plus Aerochamber Plus included in group 2
Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.
Sponsors
AstraZeneca
Western Sky Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI
Exclusion criteria
* Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV-1/FVC | 0,5,10,15,30,60,120,240,480,720 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional First This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber | 8 |
| 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 | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Spacer First | Conventional First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 7 | 37 years STANDARD_DEVIATION 7 | 36.5 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
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.
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.
Time frame: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | 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 |
| Group 2 | 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. | 2.79 Liters X hours |
Comparison: The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.p-value: 0.76t-test, 2 sided
p-value: >0.05t-test, 2 sided
Secondary
FEV-1/FVC
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.
Time frame: 0,5,10,15,30,60,120,240,480,720 minutes
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | FEV-1/FVC | 15 minutes | 79.08 percentage of fev1/fvc | Standard Deviation 10.8 |
| Group 1 | FEV-1/FVC | 120 minutes | 80.94 percentage of fev1/fvc | Standard Deviation 13.95 |
| Group 1 | FEV-1/FVC | 5 minutes | 79.08 percentage of fev1/fvc | Standard Deviation 12.07 |
| Group 1 | FEV-1/FVC | 60 minutes | 78.05 percentage of fev1/fvc | Standard Deviation 15.3 |
| Group 1 | FEV-1/FVC | 240 minutes | 81.56 percentage of fev1/fvc | Standard Deviation 14.3 |
| Group 1 | FEV-1/FVC | 30 minutes | 80.17 percentage of fev1/fvc | Standard Deviation 14.32 |
| Group 1 | FEV-1/FVC | 480 minutes | 79.95 percentage of fev1/fvc | Standard Deviation 14.43 |
| Group 1 | FEV-1/FVC | 10 minutes | 78.55 percentage of fev1/fvc | Standard Deviation 13.53 |
| Group 1 | FEV-1/FVC | 720 minutes | 79.93 percentage of fev1/fvc | Standard Deviation 12.54 |
| Group 1 | FEV-1/FVC | 0 time | 76.13 percentage of fev1/fvc | Standard Deviation 11.7 |
| Group 2 | FEV-1/FVC | 720 minutes | 80.33 percentage of fev1/fvc | Standard Deviation 13.36 |
| Group 2 | FEV-1/FVC | 120 minutes | 81.40 percentage of fev1/fvc | Standard Deviation 15.97 |
| Group 2 | FEV-1/FVC | 0 time | 75.58 percentage of fev1/fvc | Standard Deviation 12.5 |
| Group 2 | FEV-1/FVC | 5 minutes | 79.91 percentage of fev1/fvc | Standard Deviation 14.33 |
| Group 2 | FEV-1/FVC | 10 minutes | 81.16 percentage of fev1/fvc | Standard Deviation 15.08 |
| Group 2 | FEV-1/FVC | 15 minutes | 80.29 percentage of fev1/fvc | Standard Deviation 13.13 |
| Group 2 | FEV-1/FVC | 30 minutes | 80.55 percentage of fev1/fvc | Standard Deviation 15.11 |
| Group 2 | FEV-1/FVC | 240 minutes | 82.42 percentage of fev1/fvc | Standard Deviation 13.75 |
| Group 2 | FEV-1/FVC | 480 minutes | 80.56 percentage of fev1/fvc | Standard Deviation 13.94 |
| Group 2 | FEV-1/FVC | 60 minutes | 81.63 percentage of fev1/fvc | Standard Deviation 14.63 |
Comparison: The cross over means there were 16 determinants for each time for each treatmentp-value: 0.76t-test, 2 sided