Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01232894
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Indacaterol Drug: Long-acting beta2-agonist Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Indacaterol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
 Drug: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Active Comparator: Long-acting beta2-agonist
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
 Drug: Long-acting beta2-agonist
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline on Clinical COPD Questionnaire (CCQ) Score [ Time Frame: Baseline and 12 weeks ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232894


Locations
Layout table for location information
Israel
Novartis Investigative Site
Afula, Israel
Novartis Investigative Site
Ashkelon, Israel
Novartis Investigative Site
Holon, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Kfar Saba, Israel
Novartis Investigative Site
Petach Tikva, Israel
Novartis Investigative Site
Rehovot, Israel
Novartis Investigative Site
Tel Aviv, Israel
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01232894    
Other Study ID Numbers: CQAB149BIL01
First Posted: November 2, 2010    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
indacaterol
COPD
Long-acting beta2-agonist (LABA)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases