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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232894
• Other study ID #: CQAB149BIL01
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2010
• Last updated: November 18, 2013
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
• Long-acting beta2-agonist
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No