NCT01232894

Brief Summary

In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 19, 2013

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

November 1, 2010

Results QC Date

May 21, 2013

Last Update Submit

November 18, 2013

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

indacaterolCOPDLong-acting beta2-agonist (LABA)

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline on Clinical COPD Questionnaire (CCQ) Score

    The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.

    Baseline and 12 weeks

Study Arms (2)

Indacaterol

EXPERIMENTAL

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Drug: Indacaterol

Long-acting beta2-agonist

ACTIVE COMPARATOR

Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy

Drug: Long-acting beta2-agonist

Interventions

IndacaterolDRUG

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Indacaterol
Long-acting beta2-agonistDRUG

Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Long-acting beta2-agonist

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
  • Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

You may not qualify if:

  • Patients with a history of asthma
  • Patients who are currently being treated for COPD with tiotropium (Spiriva®)
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Patients with a history of certain cardiovascular comorbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Afula, Israel

Location

Novartis Investigative Site

Ashkelon, Israel

Location

Novartis Investigative Site

Holon, Israel

Location

Novartis Investigative Site

Jerusalem, Israel

Location

Novartis Investigative Site

Kfar Saba, Israel

Location

Novartis Investigative Site

Petah Tikva, Israel

Location

Novartis Investigative Site

Rehovot, Israel

Location

Novartis Investigative Site

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis
41 61 324 1111

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 19, 2013

Results First Posted

November 19, 2013

Record last verified: 2013-11

Locations

IL(8)