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

NCT00624702 | Completed Phase 1

• 1 other identifier: CQAB149B2102
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asthma

Keywords

Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)

Outcome Measures

Primary Outcomes (5)

• Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)

  throughout the study

• Severity of cough: to be judged independently by both the patient and the physician

  throughout the study

• Occurrence of cough within 1 minute post dose

  throughout the study

• Number of coughs

  throughout the study

• Duration of coughing

  throughout the study

Secondary Outcomes (5)

• Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)

  throughout the study

• Severity of cough: to be judged independently by both the patient and the physician

  throughout the study

• Occurrence of cough within 1 minute post dose

  throughout the study

• Number of coughs

  throughout the study

• Duration of coughing

  throughout the study

Study Arms (4)

1

ACTIVE COMPARATOR

Active Comparator 1 different salt formulation of Indacaterol.

Drug: Indacaterol maleate

2

ACTIVE COMPARATOR

Active Comparator 2 different salt formulation of Indacaterol.

Drug: Indacaterol maleate

3

ACTIVE COMPARATOR

Active Comparator 3 different salt formulation of Indacaterol.

Drug: Indacaterol maleate

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Indacaterol maleate DRUG

Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval

1

Placebo DRUG

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Novartis Investigator Site

Ottawa, Ontario, Canada

Location

Novartis Investigator Site

Montreal, Quebec, Canada

Location

Related Links

• Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Asthma; Cough

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 19, 2020

Record last verified: 2010-08

Locations

CA (2)