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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00403637
First received: November 6, 2006
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Asthma
Drug: indacaterol maleate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • FEV1 at time points 30 min, 1, 2 and 4 h post-dose
  • 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
  • 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

Enrollment: 45
Study Start Date: November 2006
Estimated Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403637

Locations
United States, Colorado
Colorado Allergy and Asthma Centres, P.C.
Denver, Colorado, United States, 80230
United States, Massachusetts
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
The Clinical Research Center
St Louis, Missouri, United States, 63141
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27606
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403637     History of Changes
Other Study ID Numbers: CQAB149A2228
Study First Received: November 6, 2006
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Asthma, indacaterol, long acting β2-agonist

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014