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OpenTrials
Completed

NCT Number: NCT00624702

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigator Site, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

Primary outcomes

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

    Time frame: throughout the study

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

    Time frame: throughout the study

  3. Occurrence of cough within 1 minute post dose

    Time frame: throughout the study

  4. Number of coughs

    Time frame: throughout the study

  5. Duration of coughing

    Time frame: throughout the study

Secondary outcomes

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

    Time frame: throughout the study

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

    Time frame: throughout the study

  3. Occurrence of cough within 1 minute post dose

    Time frame: throughout the study

  4. Number of coughs

    Time frame: throughout the study

  5. Duration of coughing

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2008
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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