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

Phase 2CompletedNCT01959412

Novartis Pharmaceuticals91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Indacaterol 27.5 mcgDRUG

indacaterol 27.5 mcg twice daily inhaled once via inhaler

Indacaterol 37.5DRUG

Indacaterol 37.5 mcg once daily, inhaled once via inhaler

Indacaterol 55 mcgDRUG

Indacaterol 55 mcg once daily, inhaled once via inhaler

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Novartis Investigative Site

Huntington Beach, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Mission Viejo, California, United States

Outcomes

Primary Outcomes

Change From Period Baseline in FEV1 (L) AUC(0-24h)

Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.

Time frame: Day 1 (24 hours)

Secondary Outcomes

Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)

Time frame: Day 1 (12 hours)

Change From Period Baseline in Peak FEV1 (L)

Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.

Time frame: Day 1 (24 hours)

Change From Period Baseline in Trough FEV1 (L)

Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.

Time frame: Day 1 (24 hours)

Change From Period Baseline in FVC (L) AUC (0-24h)

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

Time frame: Day 1 (24 hours)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.