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Comparing Bronchodilation of Symbicort With and With Out Valved Holding Chamber (Aerochamber Plus) (WSMR2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915538
Recruitment Status : Unknown
Verified June 2009 by Western Sky Medical Research.
Recruitment status was:  Recruiting
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Information provided by:
Western Sky Medical Research

Brief Summary:
This study will compare the amount of bronchial tube relaxation from the formoterol medicine contained in the symbicort pMeterd Dose Inhaler( 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: pMD Symbicort 160/4.5 Drug: Symbicort Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of the Bronchodilating Activity of Symbicort pMDI 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus)
Study Start Date : May 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Conventional First
This group will use pMDI in usual fashion first and cross over to pMDI and valved holding chamber
Drug: pMD Symbicort 160/4.5
The subjects will receive Symbicort pMDI 160/4.5 pMDI used in conventional fashion, and have pulmonary function measured over 12 hours. Secondly on another day, they will receive pMDI using a valved holding chamber
Other Names:
  • Symbicort
  • Aerochamber plus

Experimental: 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
Drug: Symbicort
Symbicort 160/4.5 will be administered first first through a valved holding chamber, and on another day in the conventional fashion. Pulmonary functions will be measured ove r12 hours
Other Name: Aerochamber plus

Primary Outcome Measures :
  1. 12 hour AUC of FEV-1 [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. Changes in FEV-1/FVC [ Time Frame: 12 hour ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Asthma with 15% or more increase in FEV-1 after 180-260 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 identifier (NCT number): NCT00915538

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Contact: Catherine Posey, CCRC 915-544-2557
Contact: Lyndon E Mansfield, MD CPI 915-544-2557

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United States, Texas
Western Sky Medical Research Recruiting
El Paso, Texas, United States, 79903
Contact: Catherine Posey, CCRC    915-544-2557   
Contact: Lyndon E Mansfield, MD CPI    915-544-2557   
Principal Investigator: Lyndon E Mansfield, MD CPI         
Sponsors and Collaborators
Western Sky Medical Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lyndon E. Mansfield, Western Sky Medical Research Identifier: NCT00915538    
Other Study ID Numbers: WSMR 2008-2
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: June 8, 2009
Last Verified: June 2009
Keywords provided by Western Sky Medical Research:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents