Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

Novartis

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Indacaterol maleate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624702

CQAB149B2102

Details and patient eligibility

About

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients 18 to 65 years old (inclusive)

• Patients with mild to moderate persistent asthma

• BMI must be within the range of 18-32 kg/m2 inclusive

• Female subjects must:

  1. have been sterilized at least 6 months prior to screening
  2. be post-menopausal with no regular bleeding for at least a year prior to inclusion

Exclusion criteria

• Patients with life-threatening arrhythmias
• Patients with COPD or diabetes mellitus
• History of immunocompromise, including a positive HIV
• A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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98 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Active Comparator 1 different salt formulation of Indacaterol.

Treatment:

Drug: Indacaterol maleate

Drug: Indacaterol maleate

Drug: Indacaterol maleate

2

Active Comparator group

Description:

Active Comparator 2 different salt formulation of Indacaterol.

Treatment:

Drug: Indacaterol maleate

Drug: Indacaterol maleate

Drug: Indacaterol maleate

3

Active Comparator group

Description:

Active Comparator 3 different salt formulation of Indacaterol.

Treatment:

Drug: Indacaterol maleate

Drug: Indacaterol maleate

Drug: Indacaterol maleate

4

Placebo Comparator group

Treatment:

Drug: Placebo