Chronic Obstructive Pulmonary Disease: COPDPhase 3SYNERGYNCT01699685

Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.

A Phase 3 study testing QAB149 and NVA237 in people with Chronic Obstructive Pulmonary Disease: COPD, run by Novartis Pharmaceuticals at 11 sites in Switzerland.

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

The study purpose is to evaluate the effect of QAB149 NVA237 vs. QAB149 on static lung hyperinflation. 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?: QAB149 and NVA237
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 11 sitesSwitzerland
Study dates: Nov 2012to Jun 2014
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

Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack year history of smoking
FEV1 <80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure

Who cannot join

No COPD exacerbations within 6 weeks prior to dosing
No concomitant lung disease such as asthma
Nno requirement for long term oxygen treatment or history of lung reduction surgery
No medical conditions that would interfere with the performance of spirometry
No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Switzerland11 sites

Novartis Investigative Site
Barmelweid, 5017
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Bern, 3013
Novartis Investigative Site
Crans-Montana, 3963
Novartis Investigative Site
Faltigberg-Wald, Canton of Zurich, 8639
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Locarno, Switzerland, 6600
Novartis Investigative Site
Lugano, 6900
Novartis Investigative Site
Sankt Gallen, 9007
Novartis Investigative Site
Walenstadtberg, 8881

Other trials in Switzerland

About this study

Official title: A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.

The study purpose is to evaluate the effect of QAB149

NVA237 vs. QAB149 on static lung hyperinflation.

Read the detailed description

This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.

The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack years history of smoking, FEV1 <80% and ≥30% of the predicted normal value.

Conditions: Chronic Obstructive Pulmonary Disease: COPD
Being tested: QAB149, Placebo, NVA237
Keywords: Moderate to severe COPD patients are included, NVA, QAB
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.

QAB149Drug
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
PlaceboDrug
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
NVA237Drug
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Study groups in NCT01699685
Study group	Role	What they receive
Sequence A	Placebo comparator	Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI Receives: Drug: QAB149; Drug: Placebo
Sequence B	Active comparator	Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI Receives: Drug: QAB149; Drug: NVA237

What is being measured

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

Inspiratory Capacity (IC) Peak Value
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
Measured: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Secondary outcomes (5)

Forced Expiratory Volume in One Second (FEV1)
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations
Measured: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Inspiratory Capacity (IC)
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose
Measured: within 4h after dosing
Forced Volume Capacity (FVC)
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time
Measured: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Total Lung Capacity (TLC)
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose
Measured: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Airway Resistance (Raw)
Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes
Measured: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Timeline

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

Nov 2012Jun 2014

First posted4 Oct 2012 (estimated)
Study startNov 2012
Primary completionJun 2014
Study completionJun 2014

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 Disease: COPDStudies 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, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01699685
Sponsor's protocol ID: CNVA237ACH01
Other IDs: 2012-002362-13
Acronym: SYNERGY
Status last verified: Jan 2016
First submitted: 28 Sep 2012
Last updated: 9 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Salomon J, Stolz D, Domenighetti G, Frey JG, Turk AJ, Azzola A, Sigrist T, Fitting JW, Schmidt U, Geiser T, Wild C, Kostikas K, Clemens A, Brutsche M. Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study. Respir Res. 2017 Jan 11;18(1):13. doi: 10.1186/s12931-016-0498-1.
PubMed 28077140

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?

See locations

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All Chronic Obstructive Pulmonary Disease: COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.
ClinicalTrials.gov ID: NCT01699685
Acronym / sponsor ID: SYNERGY / CNVA237ACH01
Conditions: Chronic Obstructive Pulmonary Disease: COPD
Keywords: Moderate to severe COPD patients are included, NVA, QAB
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 9 Feb 2016

Clinical summary

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

The study purpose is to evaluate the effect of QAB149

NVA237 vs. QAB149 on static lung hyperinflation.

Detailed description

Study design

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

Arm	Type	Receives
Sequence A	Placebo comparator	Drug: QAB149, Drug: PlaceboPatients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
Sequence B	Active comparator	Drug: QAB149, Drug: NVA237Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI

Who may qualify

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

Key inclusion criteria (2 listed)

Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack year history of smoking
FEV1 <80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure

Key exclusion criteria (5 listed)

No COPD exacerbations within 6 weeks prior to dosing
No concomitant lung disease such as asthma
Nno requirement for long term oxygen treatment or history of lung reduction surgery
No medical conditions that would interfere with the performance of spirometry
No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.

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
QAB149Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI	Drug	Sequence A, Sequence B
PlaceboCapsule form in blister packs inhaled with the Novartis Concept 1 SDDPI	Drug	Sequence A
NVA237Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI	Drug	Sequence B

Primary outcome

Inspiratory Capacity (IC) Peak Value
Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).

5 secondary outcomes

Forced Expiratory Volume in One Second (FEV1)
Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Inspiratory Capacity (IC)
Time frame: within 4h after dosing
Forced Volume Capacity (FVC)
Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Total Lung Capacity (TLC)
Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Airway Resistance (Raw)
Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Results and safety

Results posted to the registry on 9 Feb 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
Sequence A	39	36
Sequence B	39	36

Primary outcome: Inspiratory Capacity (IC) Peak Value

Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours. Mean (Standard Deviation). Unit: Liters

Measure	Sequence A n = 38	Sequence B n = 38
Day 0 (n=38, 38)	2.87 (0.808)	2.94 (0.777)
Day 6 (n=36, 36)	2.99 (0.856)	2.85 (0.707)

Population analysed: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence A	0 of 39 (0%)	5 of 39 (12.8%)	Not reported
Sequence B	0 of 38 (0%)	3 of 38 (7.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28077140Salomon J, Stolz D, Domenighetti G, Frey JG, Turk AJ, Azzola A, Sigrist T, Fitting JW, Schmidt U, Geiser T, Wild C, Kostikas K, Clemens A, Brutsche M. Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study. Respir Res. 2017 Jan 11;18(1):13. doi: 10.1186/s12931-016-0498-1.

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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.

Corinne Wild, PhD study director

Novartis Pharmaceuticals

Corinne Wild, PhD study chair

Novartis Pharmaceuticals

Martin Brutsche, Prof. Dr. med. principal investigator

Cantonal Hospital of St. Gallen

11 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 QAB149 and NVA237 in people with Chronic Obstructive Pulmonary Disease: COPD, run by Novartis Pharmaceuticals at 11 sites in Switzerland.

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 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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 9 Feb 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?

Inspiratory Capacity (IC) Peak Value (time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours). 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 NCT01699685, 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 9 Feb 2016.