Chronic Obstructive Pulmonary Disease (COPD)Phase 3MOVE-ONNCT01232894
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
A Phase 3 study testing Indacaterol and Long-acting beta2-agonist in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 8 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Indacaterol and Long-acting beta2-agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesIsrael
- Study dates
- Mar 2011to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Israel8 sites
Novartis Investigative Site
Afula
Novartis Investigative Site
Ashkelon
Novartis Investigative Site
Holon
Novartis Investigative Site
Jerusalem
Novartis Investigative Site
Kfar Saba
Novartis Investigative Site
Petah Tikva
Novartis Investigative Site
Rehovot
Novartis Investigative Site
Tel Aviv
About this study
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)
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.
- Being tested
- Indacaterol, Long-acting beta2-agonist
- Keywords
- indacaterol, COPD, Long-acting beta2-agonist (LABA)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndacaterolDrug
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Long-acting beta2-agonistDrug
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 µg once-daily via single-dose dry powder inhaler Receives: Drug: Indacaterol |
| Long-acting beta2-agonist | Active comparator | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy Receives: Drug: Long-acting beta2-agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232894
- Sponsor's protocol ID
- CQAB149BIL01
- Acronym
- MOVE-ON
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2010
- Last updated
- 19 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01232894
- Acronym / sponsor ID
- MOVE-ON / CQAB149BIL01
- Keywords
- indacaterol, COPD, Long-acting beta2-agonist (LABA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 19 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Drug: IndacaterolIndacaterol 150 µg once-daily via single-dose dry powder inhaler |
| Long-acting beta2-agonist | Active comparator | Drug: Long-acting beta2-agonistParticipants' current long-acting beta2-agonist (LABA) bronchodilator therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndacaterolIndacaterol 150 µg once-daily via single-dose dry powder inhaler | Drug | Indacaterol |
| Long-acting beta2-agonistLong-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily | Drug | Long-acting beta2-agonist |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol and Long-acting beta2-agonist in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 8 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013; AzTrials last refreshed its copy on 7 Nov 2026.