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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01232894
First received: November 1, 2010
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Indacaterol
Drug: Long-acting beta2-agonist
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline on Clinical COPD Questionnaire (CCQ) Score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232894

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01232894     History of Changes
Other Study ID Numbers: CQAB149BIL01
Study First Received: November 1, 2010
Results First Received: May 21, 2013
Last Updated: November 18, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Novartis:
indacaterol
COPD
Long-acting beta2-agonist (LABA)

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014