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

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: 75 µg indacaterol maleate (PoS); Drug: 75 µg indacaterol maleate (LB); Drug: placebo to indacaterol (PoS); Drug: 37.5 µg indacaterol maleate (PoS); Drug: placebo to indacaterol (LB)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484197

CIDD001A2201

2011-001825-25 (EudraCT Number)

Details and patient eligibility

About

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with asthma
• Aged 18 or above
• Patients using inhaled corticosteroid (with or without long acting beta agonist)
• Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion criteria

• Asthma exacerbations in previous 6 months
• COPD or other pulmonary disease
• Excessive use of short acting beta agonists

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 4 patient groups

75 µg Indacaterol (LB) + Placebo (PoS)

Experimental group

Description:

75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Treatment:

Drug: placebo to indacaterol (PoS)

Drug: 75 µg indacaterol maleate (LB)

75 µg Indacaterol (PoS) + Placebo (LB)

Experimental group

Description:

75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Treatment:

Drug: 75 µg indacaterol maleate (PoS)

Drug: placebo to indacaterol (LB)

37.5 µg Indacaterol (PoS) + Placebo (LB)

Experimental group

Description:

37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Treatment:

Drug: placebo to indacaterol (LB)

Drug: 37.5 µg indacaterol maleate (PoS)

Placebo (LB) and Placebo (PoS)

Experimental group

Description:

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

Treatment:

Drug: placebo to indacaterol (PoS)

Drug: placebo to indacaterol (LB)