A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Asthma
Interventions
DRUG

75 µg indacaterol maleate (LB)

75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

DRUG

75 µg indacaterol maleate (PoS)

75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

DRUG

37.5 µg indacaterol maleate (PoS)

37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

DRUG

placebo to indacaterol (LB)

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

DRUG

placebo to indacaterol (PoS)

Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Trial Locations (2)

65187

Novartis Investigative Site, Wiesbaden

M23 9QZ

Novartis Investigative Site, Machester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY

NCT01484197 - A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device | Biotech Hunter | Biotech Hunter