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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Western Sky Medical Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Western Sky Medical Research
ClinicalTrials.gov Identifier:
NCT00915538
First received: June 4, 2009
Last updated: June 5, 2009
Last verified: June 2009
  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)

Resource links provided by NLM:


Further study details as provided by Western Sky Medical Research:

Primary Outcome Measures:
  • 12 hour AUC of FEV-1 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in FEV-1/FVC [ Time Frame: 12 hour ] [ Designated as safety issue: No ]

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:
  • 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 Names:
  • Symbicort
  • Aerochamber plus

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915538

Contacts
Contact: Catherine Posey, CCRC 915-544-2557 catposey@westernskymed.com
Contact: Lyndon E Mansfield, MD CPI 915-544-2557 immunman@westernskymed.com

Locations
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         
Sponsors and Collaborators
Western Sky Medical Research
AstraZeneca
  More Information

No publications provided

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

Keywords provided by Western Sky Medical Research:
Asthma
Formoterol
LABA
Symbicort
Aerochamber

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014