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

Sandoz

Status and phase: Completed; Phase 2

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927758

CP-Sandoz-2009-PilotFP

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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105 participants in 6 patient groups

Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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

Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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

Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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

Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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

Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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

Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg

Active Comparator group

Description:

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.

Treatment:

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