Conditions: Healthy
Keywords: long-acting beta agonist (LABA) corticosteroid pMDI inhaler
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 52
Healthy volunteers: yes

Brief summary:
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

Detailed description:
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Arms:
arm 1: salmeterol and fluticasone propionate, 2 puffs arm 2: salmeterol and fluticasone propionate, 2 puffs arm 3: salmeterol and fluticasone propionate, 6 puffs arm 4: salmeterol and fluticasone propionate, 6 puffs arm 5: salmeterol and fluticasone propionate, 12 puffs arm 6: salmeterol and fluticasone propionate, 12 puffs

Interventions: intervention 1: Salmeterol intervention 2: fluticasone propionate
Intervention descriptions: intervention 1: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs intervention 2: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

Protocol document: