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CompletedNCT01699685SYNERGYUpdated Feb 9, 2016Results posted

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

A Phase 3 interventional study of QAB149 and Placebo in Chronic Obstructive Pulmonary Disease: COPD, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Switzerland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease: COPD

Keywords

  • Moderate to severe COPD patients are included
  • NVA
  • QAB
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 79 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
79 participants (actual)

Study arms

  • Placebo comparator
    Sequence A

    Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI

    Drug: QAB149 · Drug: Placebo

  • Active comparator
    Sequence B

    Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI

    Drug: QAB149 · Drug: NVA237

Interventions

  • DrugQAB149

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

  • DrugPlacebo

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

  • DrugNVA237

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Secondary outcomes

  1. 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

    Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

  2. 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

    Time frame: within 4h after dosing

  3. 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

    Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

  4. 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

    Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

  5. 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

    Time frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

07

Results

Posted Feb 9, 2016

Participant flow

Period 1
Participant flow — Period 1
MilestoneSequence ASequence B
Started3939
Safety population3938
Full analysis population (fas)3838
Completed3636
Not completed33
Withdrew: Adverse event11
Withdrew: Medical or ethical, noncompliance20
Withdrew: Other01
Withdrew: Patient request01
Period 2
Participant flow — Period 2
MilestoneSequence ASequence B
Started3636
Completed3536
Not completed10
Withdrew: Lost to follow-up10

Outcome measures

PrimaryInspiratory 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).

Time frame:
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Reported as:
Mean · Liters
Inspiratory Capacity (IC) Peak Value
LitersSequence ASequence B
Day 0 (n=38, 38)2.87 ± 0.8082.94 ± 0.777
Day 6 (n=36, 36)2.99 ± 0.8562.85 ± 0.707
SecondaryForced 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

Time frame:
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Reported as:
Mean · Liters
Forced Expiratory Volume in One Second (FEV1)
LitersSequence ASequence B
Day (0) 30 min post-dose1.49 ± 0.4421.57 ± 0.505
Day (0) 1 hour post-dose1.50 ± 0.4401.60 ± 0.506
Day (0) 2 hour post-dose1.51 ± 0.4371.60 ± 0.506
Day (0) 3 hour post-dose1.53 ± 0.4301.59 ± 0.500
Day (0) 4 hour post-dose1.53 ± 0.4341.60 ± 0.492
Day (6) 30 min post-dose1.59 ± 0.4371.52 ± 0.473
Day (6) 1 hour post-dose1.63 ± 0.4651.53 ± 0.463
Day (6) 2 hour post-dose1.66 ± 0.4621.55 ± 0.476
Day (6) 3 hour post-dose1.65 ± 0.4551.56 ± 0.470
Day (6) 4 hour post-dose1.64 ± 0.4731.56 ± 0.459
SecondaryInspiratory 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

Time frame:
within 4h after dosing
Reported as:
Mean · Liters
Inspiratory Capacity (IC)
LitersSequence ASequence B
Day (0) 30 min post-dose2.67 ± 0.7712.75 ± 0.751
Day (0) 1 hour post-dose2.67 ± 0.7992.79 ± 0.774
Day (0) 2 hour post-dose2.69 ± 0.8032.71 ± 0.709
Day (0) 3 hour post-dose2.74 ± 0.8112.69 ± 0.800
Day (0) 4 hour post-dose2.74 ± 0.8232.74 ± 0.754
Day (6) 30 min post-dose2.79 ± 0.8262.40 ± 0.724
Day (6) 1 hour post-dose2.80 ± 0.8102.72 ± 0.759
Day (6) 2 hour post-dose2.86 ± 0.8462.74 ± 0.689
Day (6) 3 hour post-dose2.83 ± 0.8412.69 ± 0.719
Day (6) 4 hour post-dose2.85 ± 0.7992.68 ± 0.699
SecondaryForced 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

Time frame:
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Reported as:
Mean · Liters
Forced Volume Capacity (FVC)
LitersSequence ASequence B
Day (0) 30 min post-dose2.98 ± 0.9173.00 ± 0.839
Day (0) 1 hour post-dose3.00 ± 0.9663.02 ± 0.846
Day (0) 2 hour post-dose3.01 ± 0.9473.04 ± 0.862
Day (0) 3 hour post-dose3.08 ± 0.9463.04 ± 0.872
Day (0) 4 hour post-dose3.07 ± 0.9683.07 ± 0.852
Day (6) 30 min post-dose3.19 ± 1.0022.96 ± 0.788
Day (6) 1 hour post-dose3.25 ± 1.0472.97 ± 0.807
Day (6) 2 hour post-dose3.29 ± 1.0182.99 ± 0.754
Day (6) 3 hour post-dose3.32 ± 1.0032.98 ± 0.794
Day (6) 4 hour post-dose3.30 ± 1.0122.96 ± 0.797
SecondaryTotal 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

Time frame:
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Reported as:
Mean · Liters
Total Lung Capacity (TLC)
LitersSequence ASequence B
Day (0) 30 min post-dose7.20 ± 1.5876.81 ± 1.144
Day (0) 1 hour post-dose7.17 ± 1.5596.79 ± 1.197
Day (0) 2 hour post-dose7.06 ± 1.6586.81 ± 1.190
Day (0) 3 hour post-dose7.14 ± 1.6626.82 ± 1.198
Day (0) 4 hour post-dose7.21 ± 1.6086.78 ± 1.247
Day (6) 30 min post-dose7.20 ± 1.6646.79 ± 1.243
Day (6) 1 hour post-dose7.12 ± 1.5766.80 ± 1.312
Day (6) 2 hour post-dose7.21 ± 1.6416.80 ± 1.213
Day (6) 3 hour post-dose7.23 ± 1.5616.81 ± 1.304
Day (6) 4 hour post-dose7.30 ± 1.6916.93 ± 1.376
SecondaryAirway 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

Time frame:
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Reported as:
Mean · cmH2O/l/s
Airway Resistance (Raw)
cmH2O/l/sSequence ASequence B
Day (0) 30 min post-dose5.13 ± 2.2434.74 ± 1.810
Day (0) 1 hour post-dose5.19 ± 2.5614.61 ± 1.881
Day (0) 2 hour post-dose5.21 ± 2.4964.43 ± 1.849
Day (0) 3 hour post-dose5.07 ± 2.5284.53 ± 1.748
Day (0) 4 hour post-dose5.18 ± 2.5354.48 ± 1.866
Day (6) 30 min post-dose4.73 ± 2.5405.18 ± 2.130
Day (6) 1 hour post-dose4.47 ± 2.3234.97 ± 1.861
Day (6) 2 hour post-dose4.31 ± 2.1194.71 ± 1.822
Day (6) 3 hour post-dose4.30 ± 2.1614.77 ± 1.989
Day (6) 4 hour post-dose4.30 ± 2.1704.78 ± 1.939

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sequence A—0/39 (0%)5/39 (12.8%)
Sequence B—0/38 (0%)3/38 (7.9%)
Most frequent other events
Most frequent other events
EventSequence ASequence B
Forced expiratory volume decreasedInvestigations1/391/38
ArthralgiaMusculoskeletal and connective tissue disorders0/391/38
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/391/38
NasopharyngitisInfections and infestations1/390/38
Inspiratory capacity decreasedInvestigations1/390/38
Lung disorderRespiratory, thoracic and mediastinal disorders1/390/38

Baseline characteristics

Demographic summary by treatment group (safety population, N = 77)

Age, Continuous
Age, Continuous(Years)Sequence ASequence BTotal
Mean65.62 ± 9.24764.18 ± 7.44764.91 ± 8.383
Sex: Female, Male
Sex: Female, Male(Participants)Sequence ASequence BTotal
Female141731
Male252146
08

Study locations

11 sites
  • Novartis Investigative Site
    Faltigberg-Wald, Canton of Zurich 8639, Switzerland
  • Novartis Investigative Site
    Basel, Switzerland 4031, Switzerland
  • Novartis Investigative Site
    Locarno, Switzerland 6600, Switzerland
  • Novartis Investigative Site
    Barmelweid, 5017, Switzerland
  • Novartis Investigative Site
    Bern, 3010, Switzerland
  • Novartis Investigative Site
    Bern, 3013, Switzerland
  • Novartis Investigative Site
    Crans-Montana, 3963, Switzerland
  • Novartis Investigative Site
    Lausanne, 1011, Switzerland
  • Novartis Investigative Site
    Lugano, 6900, Switzerland
  • Novartis Investigative Site
    Sankt Gallen, 9007, Switzerland
  • Novartis Investigative Site
    Walenstadtberg, 8881, Switzerland
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2016, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2012
First posted
Oct 4, 2012
Start
Nov 2012
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Results first posted
Feb 9, 2016
Last update
Feb 9, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01699685
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 4, 2012
Start date
Nov 2012
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Feb 9, 2016
Last update
Feb 9, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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