Comparing Bronchodilation of Symbicort With and With Out Valved Holding Chamber (Aerochamber Plus)
Information source: Western Sky Medical Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: pMD Symbicort 160/4.5 (Drug); Symbicort (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Western Sky Medical Research Overall contact:
Catherine Posey, CCRC, Phone: 915-544-2557, Email: catposey@westernskymed.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Primary outcome: 12 hour AUC of FEV-1
Secondary outcome: Changes in FEV-1/FVC
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Catherine Posey, CCRC, Phone: 915-544-2557, Email: catposey@westernskymed.com
Western Sky Medical Research, El Paso, Texas 79903, United States; Recruiting
Catherine Posey, CCRC, Phone: 915-544-2557, Email: catposey@westernskymed.com
Lyndon E Mansfield, MD CPI, Phone: 915-544-2557, Email: immunman@westernskymed.com
Lyndon E Mansfield, MD CPI, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: September 2009
Last updated: June 5, 2009
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