Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 / use of pMDI as approved | Other | The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (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. |
|
| Group 2 / pMDI with Aerochamber Plus | Experimental | 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pMDI budesonide/formotrol 160/4.5 is in group 1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0,5,10,15,30,60,120,240,480,720 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lyndon E Mansfield, MD | Western Sky Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Sky Medical Research | El Paso | Texas | 79903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15654001 | Background | Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335. | |
| 16122401 |
Not provided
Not provided
The results were published in the Journal of Asthma . 2013 Feb :50(1)71-4. Dr. Mansfield was the corresponding author and could be reached by email or phone regarding the study.
February 2013
Query to the corresponding author
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Conventional First | This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Conventional First | This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | Liters X hours | BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs) |
|
Adverse events were collected during a period of two weeks (the study duration).
No source vocabulary was used as there were no adverse events to record. No table was formed because of no data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional | This group will use pMDI in usual fashion |
Not provided
Not provided
No subject discontinued subjects were adults experienced in using a pressured metered dose inhaler (pMDI), Spacers or holding chambers are most frequently used by patients with coordination difficulties.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndon Mansfield MD | Western Sky Medical Research | 915-544-2557 | immunman@westernskymed.com |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Symbicort 160/4.5 plus Aerochamber Plus included in group 2 | Device | 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. |
|
|
| Background |
| Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90. |
| 18501026 | Background | Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5. |
| 23176189 | Derived | Mansfield LE, Maynes R. A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler. J Asthma. 2013 Feb;50(1):71-4. doi: 10.3109/02770903.2012.745093. Epub 2012 Nov 26. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of fev1/fvc | 0,5,10,15,30,60,120,240,480,720 minutes |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Spacer | This arm will receive pMDI and Valved holding chamber | 0 | 16 | 0 | 16 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| 10 minutes |
|
| 15 minutes |
|
| 30 minutes |
|
| 60 minutes |
|
| 120 minutes |
|
| 240 minutes |
|
| 480 minutes |
|
| 720 minutes |
|