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

Sponsor:	Sandoz Inc.
Information provided by:	Sandoz
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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Fluticasone, salmeterol drug combination

U.S. FDA Resources

Further study details as provided by Sandoz:

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
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0486
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Sandoz Inc.

More Information

No publications provided

Responsible Party:	Eric Mittleberg, Ph.D. VP Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00927758 History of Changes
Other Study ID Numbers:	CP-Sandoz-2009-PilotFP
Study First Received:	June 23, 2009
Last Updated:	February 24, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 24, 2012