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

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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

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

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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