Chronic Obstructive Pulmonary DiseasePhase 3MOVENCT01996319

Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD.

A Phase 3 study testing QVA149 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 30 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: QVA149
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 194 participants
Where: 30 sitesGermany
Study dates: Apr 2014to Feb 2015
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

Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70

Who cannot join

Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 4 weeks prior to screening.
Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Germany30 sites

Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Berlin, State of Berlin, 10119
Novartis Investigative Site
Berlin, 10629
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Cologne, 51605
Novartis Investigative Site
Cottbus, Saxony, 03050
Novartis Investigative Site
Düren, 52349
Novartis Investigative Site
Erlangen, 91052
Novartis Investigative Site
Euskirchen, 53879
Novartis Investigative Site
Geesthacht, Schleswig-Holstein, 12502
Novartis Investigative Site
Großhansdorf, 22947
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Heidelberg, Germany, 69117
Novartis Investigative Site
Höchstadt an der Aisch, 91315
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Koblenz, North Rhine-Westphalia, 56068
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04207
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Lübeck, 23558
Novartis Investigative Site
Marburg, 35037
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Neunkirchen, 66539
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Potsdam, 14469
Novartis Investigative Site
Rheine, 48431
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Saarbrücken, 66111
Novartis Investigative Site
Teterow, Germany, 17166
Novartis Investigative Site
Wiesloch, 69168

Other trials in Germany

About this study

Official title: MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: QVA149, Placebo
Keywords: Chronic obstructive pulmonary disease, COPD
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.

QVA149Drug
QVA149 (110/50 µg) once a day via Breezhaler® device
PlaceboDrug
Placebo once a day via Breezhaler® device

Study groups in NCT01996319
Study group	Role	What they receive
Treatment sequence I	Active comparator	QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days Receives: Drug: QVA149; Drug: Placebo
Treatment sequence II	Active comparator	Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days Receives: Drug: QVA149; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo
Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57
Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level
Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57

Secondary outcomes (6)

Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day
The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day 1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57
Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo
Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57
Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.
Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
Measured: Day 1 or day 36
Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo
Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57
Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
Measured: Day 1 or day 36
Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Measured: Baseline, day 22, baseline day 36, day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Feb 2015

First posted27 Nov 2013 (estimated)
Study startApr 2014
Primary completionFeb 2015
Study completionFeb 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996319
Sponsor's protocol ID: CQVA149ADE03
Acronym: MOVE
Status last verified: Mar 2016
First submitted: 15 Nov 2013
Last updated: 5 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Watz H, Mailander C, Baier M, Kirsten A. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study). BMC Pulm Med. 2016 Jun 14;16(1):95. doi: 10.1186/s12890-016-0256-7.
PubMed 27301417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01996319
Acronym / sponsor ID: MOVE / CQVA149ADE03
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease, COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Posted 5 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Treatment sequence I	Active comparator	Drug: QVA149, Drug: PlaceboQVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days
Treatment sequence II	Active comparator	Drug: QVA149, Drug: PlaceboPlacebo once a day during 21 days cross-over to QVA149 once a day for 21 days

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70

Key exclusion criteria (8 listed)

Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

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
QVA149QVA149 (110/50 µg) once a day via Breezhaler® device	Drug	Treatment sequence I, Treatment sequence II
PlaceboPlacebo once a day via Breezhaler® device	Drug	Treatment sequence I, Treatment sequence II

Primary outcome

Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo
Time frame: Baseline, day 22, baseline day 36, day 57
Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level
Time frame: Baseline, day 22, baseline day 36, day 57
Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36

6 secondary outcomes

Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day
Time frame: Baseline, day 22, baseline day 36, day 57
Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo
Time frame: Baseline, day 22, baseline day 36, day 57
Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.
Time frame: Day 1 or day 36
Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo
Time frame: Baseline, day 22, baseline day 36, day 57
Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1
Time frame: Day 1 or day 36
Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days
Time frame: Baseline, day 22, baseline day 36, day 57

Results and safety

Results posted to the registry on 5 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QVA149 Then Placebo	96	88
Placebo Then QVA149	98	95

Primary outcome: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo

Time frame: Baseline, day 22, baseline day 36, day 57. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	QVA149 n = 189	Placebo n = 184
Value	0.3790 (0.2747)	0.1769 (0.1933)

QVA149 vs Placebo: null hypoth: 0.2021 (95% CI 0.1583 to 0.2460), p <0.0001, ANCOVA

Population analysed: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.

Primary outcome: Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level

Time frame: Baseline, day 22, baseline day 36, day 57. Least squares mean (95% Confidence Interval). Unit: kcal/day

Measure	QVA149 n = 175	Placebo n = 170
Value	5.1063 (214.6)	-31.6063 (233.0)

QVA149 vs Placebo: Null hypoth: 36.7126 (95% CI 1.7241 to 71.7011), p = 0.0399, ANCOVA

Population analysed: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149 Then Placebo	4 of 193 (2.1%)	27 of 193 (14%)	Not reported
Placebo Then QVA149	2 of 188 (1.1%)	19 of 188 (10.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27301417Watz H, Mailander C, Baier M, Kirsten A. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study). BMC Pulm Med. 2016 Jun 14;16(1):95. doi: 10.1186/s12890-016-0256-7.

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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

30 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 QVA149 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 30 sites in Germany.

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 2 inclusion and 8 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. 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 5 Apr 2016). 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 in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (time frame: Baseline, day 22, baseline day 36, day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01996319, which also lists 1 linked publication.

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 5 Apr 2016.