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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz Inc.
ClinicalTrials.gov Identifier:
NCT00927758
First received: June 23, 2009
Last updated: June 4, 2013
Last verified: November 2009
History of Changes
  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
Official Title: Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair

Resource links provided by NLM:

MedlinePlus related topics: Asthma
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 ]

Enrollment: 105
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: 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: June 4, 2013
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
Nitric Oxide
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Adrenergic beta-2 Receptor Agonists

ClinicalTrials.gov processed this record on June 18, 2013