Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma (QAB149)

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Indacaterol 150 mcg; Drug: Indacaterol 27.5 mcg; Drug: Indacaterol 37.5; Drug: Placebo; Drug: Indacaterol 75 mcg; Drug: Indacaterol 55 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959412

CQVA149A2210

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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91 participants in 6 patient groups

Treatment Period Sequence 1

Experimental group

Description:

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

Treatment:

Drug: Indacaterol 27.5 mcg

Drug: Placebo

Treatment Period Sequence 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Indacaterol 37.5

Treatment Period Sequence 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Indacaterol 55 mcg

Treatment Sequence Period 4

Experimental group

Description:

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

Treatment:

Drug: Indacaterol 75 mcg

Drug: Placebo

Treatment Period Sequence 5

Experimental group

Description:

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

Treatment:

Drug: Indacaterol 150 mcg

Drug: Placebo

Treatment Period Sequence 6

Experimental group

Description:

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

Treatment:

Drug: Placebo