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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: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study |
| 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 |
|---|---|
|
Conventional First: Experimental
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
|
|
Spacer First: Experimental
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
|
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: | Western Sky Medical Research ( Lyndon E. Mansfield ) |
| Study ID Numbers: | WSMR 2008-2 |
| Study First Received: | June 4, 2009 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00915538 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Asthma Formoterol LABA Symbicort Aerochamber |
|
Respiratory System Agents Bronchial Diseases Immune System Diseases Symbicort Asthma Anti-Asthmatic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |
