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

March 27, 2017 updated by: Sandoz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-0486
        • University of Florida
    • Iowa
      • Iowa City, Iowa, United States, 52244
        • CompleWare
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS
Active Comparator: Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS
Active Comparator: Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS
Active Comparator: Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS
Active Comparator: Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS
Active Comparator: Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg

Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.

Treatment Cycle 3: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.

There were 14 days washout period between cycles.
Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
fluticasone propionate/salmeterol diskus
Other Names:
  • Advair DISKUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
Time Frame: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-Sandoz-2009-PilotFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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