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Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus) (WSMR2)

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ClinicalTrials.gov Identifier: NCT00915538
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Lyndon Mansfield, Western Sky Medical Research

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: pMDI budesonide/formotrol 160/4.5 is in group 1 Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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)
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
Group 1 / use of pMDI as approved
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.
Drug: pMDI 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.
Other Name: Symbicort

Device: Symbicort 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.
Other Names:
  • Symbicort
  • Aerochamber plus

Experimental: Group 2 / pMDI with Aerochamber Plus
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..
Drug: pMDI 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.
Other Name: Symbicort

Device: Symbicort 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.
Other Names:
  • Symbicort
  • Aerochamber plus




Primary Outcome Measures :
  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. [ Time Frame: 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 Outcome Measures :
  1. FEV-1/FVC [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915538


Locations
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United States, Texas
Western Sky Medical Research
El Paso, Texas, United States, 79903
Sponsors and Collaborators
Western Sky Medical Research
AstraZeneca
Investigators
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Principal Investigator: Lyndon E Mansfield, MD Western Sky Medical Research
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lyndon Mansfield, Director, Western Sky Medical Research
ClinicalTrials.gov Identifier: NCT00915538    
Other Study ID Numbers: WSMR 2008-2
First Posted: June 8, 2009    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: February 2013
Access Criteria: Query to the corresponding author
Keywords provided by Lyndon Mansfield, Western Sky Medical Research:
Asthma
Formoterol
Long Acting Beta Adrenergic Bronchodilator
Symbicort
Aerochamber
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists