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12-week Open-label Evaluation of Efficacy and Safety of Indacaterol (MOVE-ON)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Indacaterol
Long-acting beta2-agonist
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring indacaterol, COPD, Long-acting beta2-agonist (LABA)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol

Long-acting beta2-agonist

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2010
Last Updated
November 18, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01232894
Brief Title
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Acronym
MOVE-ON
Official Title
A 12 Week, Multi-center, Randomized, Open Label Study, eValuating the Efficacy and Safety of Treatment Regimens That Include ONbrez (Indacaterol) in Patients With Moderate to Severe COPD (MOVE-ON Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
indacaterol, COPD, Long-acting beta2-agonist (LABA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Arm Title
Long-acting beta2-agonist
Arm Type
Active Comparator
Arm Description
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Long-acting beta2-agonist
Intervention Description
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily
Primary Outcome Measure Information:
Title
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Afula
Country
Israel
Facility Name
Novartis Investigative Site
City
Ashkelon
Country
Israel
Facility Name
Novartis Investigative Site
City
Holon
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

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