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NCT Number: NCT00403637

Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Colorado Allergy and Asthma Centres, P.C., Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females 12 - 75 years of age with a diagnosis of persistent asthma
  • Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
  • FEV1 at Visit 1 at least 50% of the predicted normal value
  • FEV1 reversibility at least 15%

Exclusion criteria

  • Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Seasonal allergy where asthma is likely to deteriorate during the period of the study
  • Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
  • A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply

Treatment and study plan

Indacaterol maleate

Drug

Primary outcomes

  1. Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

Secondary outcomes

  1. FEV1 at time points 30 min, 1, 2 and 4 h post-dose

  2. Percent change in FEV1 at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose

  3. Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler (SDDPI) vs. Placebo in Patients With Persistent Asthma

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 27, 2006
Registry last updated
Nov 18, 2016

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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