Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
WSMR2
A Comparison of the Bronchodilating Activity of Symbicort Pressure Metered Dose Inhaler (pMDI) 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus)
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Jul 2009
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
August 13, 2020
CompletedAugust 13, 2020
August 1, 2020
1 month
June 4, 2009
September 23, 2010
August 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Secondary Outcomes (1)
FEV-1/FVC
0,5,10,15,30,60,120,240,480,720 minutes
Study Arms (2)
Group 1 / use of pMDI as approved
OTHERThe 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
EXPERIMENTALThe 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..
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western Sky Medical Researchlead
- AstraZenecacollaborator
Study Sites (1)
Western Sky Medical Research
El Paso, Texas, 79903, United States
Related Publications (4)
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.
PMID: 15654001BACKGROUNDNewman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90.
PMID: 16122401BACKGROUNDHess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
PMID: 18501026BACKGROUNDMansfield 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.
PMID: 23176189DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Lyndon Mansfield MD
- Organization
- Western Sky Medical Research
Study Officials
- PRINCIPAL INVESTIGATOR
Lyndon E Mansfield, MD
Western Sky Medical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 8, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 13, 2020
Results First Posted
August 13, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- February 2013
- Access Criteria
- Query to the corresponding author
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.