Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair

This study is currently recruiting participants.

Verified by Sandoz Inc., November 2009

First Received: June 23, 2009 Last Updated: November 5, 2009 History of Changes

Sponsor:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00927758

Purpose

To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.

Condition	Intervention	Phase
Asthma	Drug: ADVAIR (fluticasone propionate/salmeterol)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair

U.S. FDA Resources

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

To examine the post-dose changes in eNO following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ADVAIR (fluticasone propionate/salmeterol) 100mcg/50mcg: Active Comparator Comparison of different dosages of fluticasone propionate/salmeterol diskus.	Drug: ADVAIR (fluticasone propionate/salmeterol) Comparison of different dosages of fluticasone propionate/salmeterol diskus.
ADVAIR (fluticasone propionate/salmeterol) 250mcg/50mcg: Active Comparator Comparison of different dosages of fluticasone propionate/salmeterol diskus.	Drug: ADVAIR (fluticasone propionate/salmeterol) Comparison of different dosages of fluticasone propionate/salmeterol diskus.
ADVAIR (fluticasone propionate/salmeterol) 500mcg/50mcg: Active Comparator Comparison of different dosages of fluticasone propionate/salmeterol diskus.	Drug: ADVAIR (fluticasone propionate/salmeterol) Comparison of different dosages of fluticasone propionate/salmeterol diskus.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

must be able to speak, read, and understand English
exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16
must have history of at least 6 months of chronic, but stable asthma
except for the presence of asthma, subjects must be in general good health

Exclusion Criteria:

past or present history of experiencing allergic reaction to medications used in this study
subjects must not be receiving ongoing regular treatment with inhaled corticosteroids
subjects must not have ragweed allergy
subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927758

Contacts

Contact: Jurgita Zdanaviciene, BSN	608-263-6185
Contact: Alice Boyette, LPN	352-273-6183

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610-0486
Contact: Alice Boyette, LPN 352-273-6183
United States, Wisconsin
University of Wisconsin	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jurgita Zdanaviciene, BSN 608-263-6185

Sponsors and Collaborators

Sandoz Inc.

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D. VP Product Development )
Study ID Numbers:	CP-Sandoz-2009-PilotFP
Study First Received:	June 23, 2009
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00927758 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 09, 2010