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| Sponsor: | Western Sky Medical Research |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | Western Sky Medical Research |
| ClinicalTrials.gov Identifier: | NCT00915538 |
Purpose
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 | Intervention |
|---|---|
|
Asthma |
Drug: pMD Symbicort 160/4.5 Drug: Symbicort |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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) |
| Estimated Enrollment: | 16 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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 Names:
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Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Catherine Posey, CCRC | 915-544-2557 | catposey@westernskymed.com |
| Contact: Lyndon E Mansfield, MD CPI | 915-544-2557 | immunman@westernskymed.com |
| United States, Texas | |
| Western Sky Medical Research | Recruiting |
| El Paso, Texas, United States, 79903 | |
| Contact: Catherine Posey, CCRC 915-544-2557 catposey@westernskymed.com | |
| Contact: Lyndon E Mansfield, MD CPI 915-544-2557 immunman@westernskymed.com | |
| Principal Investigator: Lyndon E Mansfield, MD CPI | |
More Information
| Responsible Party: | Lyndon E. Mansfield, Western Sky Medical Research |
| ClinicalTrials.gov Identifier: | NCT00915538 History of Changes |
| Other Study ID Numbers: | WSMR 2008-2 |
| Study First Received: | June 4, 2009 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Asthma Formoterol LABA Symbicort Aerochamber |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Symbicort Budesonide Anti-Asthmatic Agents |
Respiratory System Agents Therapeutic Uses Pharmacologic Actions Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
