Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

NCT ID: NCT01959412

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Period Sequence 1

Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening

Group Type: EXPERIMENTAL

Indacaterol 27.5 mcg

Intervention Type: DRUG

indacaterol 27.5 mcg twice daily inhaled once via inhaler

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Treatment Period Sequence 2

Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening

Group Type: EXPERIMENTAL

Indacaterol 37.5

Intervention Type: DRUG

Indacaterol 37.5 mcg once daily, inhaled once via inhaler

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Treatment Period Sequence 3

Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening

Group Type: EXPERIMENTAL

Indacaterol 55 mcg

Intervention Type: DRUG

Indacaterol 55 mcg once daily, inhaled once via inhaler

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Treatment Sequence Period 4

Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening

Group Type: EXPERIMENTAL

Indacaterol 75 mcg

Intervention Type: DRUG

Indacaterol 75 mcg once daily, inhaled once via inhaler

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Treatment Period Sequence 5

Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening

Group Type: EXPERIMENTAL

Indacaterol 150 mcg

Intervention Type: DRUG

Indacaterol 150 mcg once daily, inhaled once via inhaler

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Treatment Period Sequence 6

Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Interventions

Indacaterol 27.5 mcg

indacaterol 27.5 mcg twice daily inhaled once via inhaler

Intervention Type: DRUG

Indacaterol 37.5

Indacaterol 37.5 mcg once daily, inhaled once via inhaler

Intervention Type: DRUG

Indacaterol 55 mcg

Indacaterol 55 mcg once daily, inhaled once via inhaler

Intervention Type: DRUG

Indacaterol 75 mcg

Indacaterol 75 mcg once daily, inhaled once via inhaler

Intervention Type: DRUG

Indacaterol 150 mcg

Indacaterol 150 mcg once daily, inhaled once via inhaler

Intervention Type: DRUG

Placebo

Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

Exclusion Criteria

• patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Huntington Beach, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Mission Viejo, California, United States

Novartis Investigative Site

Centennial, Colorado, United States

Novartis Investigative Site

North Dartmouth, Massachusetts, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Skillman, New Jersey, United States

Novartis Investigative Site

Raleigh, North Carolina, United States

Novartis Investigative Site

Medford, Oregon, United States

Novartis Investigative Site

Portland, Oregon, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

El Paso, Texas, United States

Countries

United States

Other Identifiers

CQVA149A2210

Identifier Type: -

Identifier Source: org_study_id