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

NCT01959412 | Completed Phase 2 Results

• 1 other identifier: CQVA149A2210
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 12

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

Keywords

wheezing, short of breath, laba, inhaler

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (24 hours)

Secondary Outcomes (4)

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

  Day 1 (12 hours)

• Change From Period Baseline in Peak FEV1 (L)

  Day 1 (24 hours)

• Change From Period Baseline in Trough FEV1 (L)

  Day 1 (24 hours)

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

  Day 1 (24 hours)

Study Arms (6)

Treatment Period Sequence 1

EXPERIMENTAL

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

Drug: Indacaterol 27.5 mcg; Drug: Placebo

Treatment Period Sequence 2

EXPERIMENTAL

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

Drug: Indacaterol 37.5; Drug: Placebo

Treatment Period Sequence 3

EXPERIMENTAL

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

Drug: Indacaterol 55 mcg; Drug: Placebo

Treatment Sequence Period 4

EXPERIMENTAL

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

Drug: Indacaterol 75 mcg; Drug: Placebo

Treatment Period Sequence 5

EXPERIMENTAL

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

Drug: Indacaterol 150 mcg; Drug: Placebo

Treatment Period Sequence 6

EXPERIMENTAL

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

Drug: Placebo

Interventions

Indacaterol 27.5 mcg DRUG

indacaterol 27.5 mcg twice daily inhaled once via inhaler

Treatment Period Sequence 1

Indacaterol 37.5 DRUG

Indacaterol 37.5 mcg once daily, inhaled once via inhaler

Treatment Period Sequence 2

Indacaterol 55 mcg DRUG

Indacaterol 55 mcg once daily, inhaled once via inhaler

Treatment Period Sequence 3

Indacaterol 75 mcg DRUG

Indacaterol 75 mcg once daily, inhaled once via inhaler

Treatment Sequence Period 4

Indacaterol 150 mcg DRUG

Indacaterol 150 mcg once daily, inhaled once via inhaler

Treatment Period Sequence 5

Placebo DRUG

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

Treatment Period Sequence 1; Treatment Period Sequence 2; Treatment Period Sequence 3; Treatment Period Sequence 5; Treatment Period Sequence 6; Treatment Sequence Period 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Novartis Investigative Site

Huntington Beach, California, 92647, United States

Location

Novartis Investigative Site

Los Angeles, California, 90048, United States

Location

Novartis Investigative Site

Mission Viejo, California, 92691, United States

Location

Novartis Investigative Site

Centennial, Colorado, 80112, United States

Location

Novartis Investigative Site

North Dartmouth, Massachusetts, 02747, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Skillman, New Jersey, 08558, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504-8741, United States

Location

Novartis Investigative Site

Portland, Oregon, 97213, United States

Location

Novartis Investigative Site

Dallas, Texas, 75231, United States

Location

Novartis Investigative Site

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Dyspnea

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 6, 2015
• Results First Posted: May 6, 2015

Record last verified: 2015-04

Locations

US (12)