A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Study Overview
Brief Summary
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •have been sterilized at least 6 months prior to screening
- •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.
Arms & Interventions
1
Active Comparator 1 different salt formulation of Indacaterol.
Intervention: Indacaterol maleate (Drug)
2
Active Comparator 2 different salt formulation of Indacaterol.
Intervention: Indacaterol maleate (Drug)
3
Active Comparator 3 different salt formulation of Indacaterol.
Intervention: Indacaterol maleate (Drug)
4
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Time Frame: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
Time Frame: throughout the study
Duration of coughing
Time Frame: throughout the study
Occurrence of cough within 1 minute post dose
Time Frame: throughout the study
Number of coughs
Time Frame: throughout the study
Secondary Outcomes
- Severity of cough: to be judged independently by both the patient and the physician(throughout the study)
- Number of coughs(throughout the study)
- Occurrence of cough within 1 minute post dose(throughout the study)
- Duration of coughing(throughout the study)
- Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)(throughout the study)