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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927758
• Other study ID #: CP-Sandoz-2009-PilotFP
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2009
• Last updated: March 27, 2017
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2014
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	CompleWare	Iowa City	Iowa
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)	Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.	Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)