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Efficacy and Safety of Different Doses of Indacaterol

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Indacaterol (Drug); Salmeterol (Drug); Placebo to Indacaterol (Drug); Placebo to Salmeterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Clinical Details

Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment

Secondary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with a diagnosis of asthma, and:

1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening 2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal 3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol Exclusion Criteria:

- Smoking history >10 pack-years

- Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

- Patients with seasonal allergy whose asthma is likely to deteriorate during the study

period

- Patients who have experienced a severe asthma attack/exacerbation requiring

hospitalization in the 6 months prior to screening

- Patients who have had an intubation for a severe asthma exacerbation

- Patients who have had an emergency room visit for an asthma attack/asthma

exacerbation within 6 weeks prior to screening

- Patients who have had a respiratory tract infection within 6 weeks prior to screening

- Patients with concomitant pulmonary disease

- Patients with diabetes Type I or uncontrolled diabetes Type II

- Any patient with lung cancer or a history of lung cancer

- Patients with a history of certain cardiovascular comorbid conditions

- Patients who have ever received or are currently receiving omalizumab or chronic oral

corticosteroid therapy Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigator Site, Glendale, Arizona 85306, United States

Novartis Investigator Site, Scottsdale, Arizona 85251, United States

Novartis Investigator Site, Encinitas, California 92024, United States

Novartis Investigator Site, Huntington Beach, California 92647, United States

Novartis Investigator Site, Los Angeles, California 90025, United States

Novartis Investigator Site, Los Angeles, California 90048, United States

Novartis Investigative Site, Mission Viejo, California 92691, United States

Novartis Investigator Site, Orange, California 92868, United States

Novartis Investigator Site, Rancho Mirage, California 92270, United States

Novartis Investigator Site, Rolling Hills Estates, California 90274, United States

Novartis Investigator Site, San Diego, California 92120, United States

Novartis Investigator Site, San Diego, California 92123, United States

Novartis Investigator Site, San Jose, California 95117, United States

Novartis Investigator Site, Stockton, California 95207, United States

Novartis Investigator Site, Colorado Springs, Colorado 80907, United States

Novartis Investigator Site, Denver, Colorado 80230, United States

Novartis Investigator Site, Engelwood, Colorado 80112, United States

Novartis Investigator Site, Lakewood, Colorado 80401, United States

Novartis Investigative Site, Stamford, Connecticut 06902, United States

Novartis Investigative Site, Waterbury, Connecticut 06708, United States

Novartis Investigative site, Destin, Florida 32541, United States

Novartis Investigative Site, Pensacola, Florida 32503, United States

Novartis Investigative Site, Pensacola, Florida 32514, United States

Novartis Investigative Site, Port Orange, Florida 32127, United States

Novartis Investigative Site, Sarasota, Florida 34233, United States

Novartis Investigative Site, Tamarac, Florida 33321, United States

Novartis Investigative Site, Winter Park, Florida 32789, United States

Novartis Investigator Site, Boise, Idaho 83704, United States

Novartis Investigator Site, Normal, Illinois 61761, United States

Novartis Investigative Site, Springfield, Illinois 62703, United States

Novartis Investigator Site, Overland Park, Kansas 66210, United States

Novartis Investigative Site, Louisville, Kentucky 40215, United States

Novartis Investigator Site, Lafayette, Louisiana 70503, United States

Novartis Investigative Site, Baltimore, Maryland 21236, United States

Novartis Investigator Site, Columbia, Maryland 21044, United States

Novartis Investigative Site, Wheaton, Maryland 20902, United States

Novartis Investigative Site, North Dartmouth, Massachusetts 02747, United States

Novartis Investigative Site, Minneapolis, Minnesota 55402, United States

Novartis Investigator Site, Columbia, Missouri 65203, United States

Novartis Investigator Site, Rolla, Missouri 65401, United States

Novartis Investigator Site, St. Louis, Missouri 63141, United States

Novartis Investigator Site, Warrensburg, Missouri 64093, United States

Novartis Investigative Site, Missoula, Montana 59808, United States

Novartis Investigator Site, Bellevue, Nebraska 68123, United States

Novartis Investigator Site, Boys Town, Nebraska 68010, United States

Novartis Investigative Site, Ocean, New Jersey 07712, United States

Novartis Investigative Site, Skillman, New Jersey 08558, United States

Novartis Investigative Site, Charlotte, North Carolina 28207, United States

Novartis Investigative Site, Raleigh, North Carolina 27607, United States

Novartis Investigator Site, Cadiz, Ohio 43907, United States

Novartis Investigative Site, Columbus, Ohio 43215, United States

Novartis Investigative Site, Maumee, Ohio 43537, United States

Novartis Investigator Site, Oklahoma City, Oklahoma 73103, United States

Novartis Investigator Site, Lake Oswego, Oregon 97035, United States

Novartis Investigative Site, Medford, Oregon 97504, United States

Novartis Investigator Site, Portland, Oregon 97213, United States

Novartis Investigative Site, Erie, Pennsylvania 16506, United States

Novartis Investigative Site, Phoenixville, Pennsylvania 19460, United States

Novartis Investigative Site, Pittsburgh, Pennsylvania 15243, United States

Novartis Investigative Site, Upland, Pennsylvania 19013, United States

Novartis Investigative Site, Lincoln, Rhode Island 02865, United States

Novartis Investigative Site, Charleston, South Carolina 29414, United States

Novartis Investigative site, North Charleston, South Carolina 29406, United States

Novartis Investigator Site, Austin, Texas 78758, United States

Novartis Investigator Site, Dallas, Texas 75231, United States

Novartis Investigator Site, El Paso, Texas 79903, United States

Novartis Investigator Site, El Paso, Texas 79925, United States

Novartis Investigator Site, Georgetown, Texas 78628, United States

Novartis Investigator Site, North Richland Hills, Texas 76180, United States

Novartis Investigator Site, Waco, Texas 73712, United States

Novartis Investigator Site, Seattle, Washington 98105, United States

Additional Information

Starting date: February 2010
Last updated: July 22, 2011

Page last updated: August 23, 2015

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