Chronic Obstructive Pulmonary DiseasePhase 3ENLIGHTENNCT01120717

A Study to Assess the Long-term Safety of QVA149

A Phase 3 study testing QVA149 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 53 sites in 10 countries.

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 is designed to provide long-term safety data for QVA149 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 339 participants
Where: 53 sitesin 10 countries
Study dates: Apr 2010to Dec 2011
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 or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Who cannot join

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

Show all 9Show fewer

Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

53 sites in 10 countries.

Country

City, postcode or hospital

53 sites in 10 countries

India9 sites

Novartis Investigative Site
Banglaore, Karnataka, 560027
Novartis Investigative Site
Chennai - Tamil Nadu, India, 600 087
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641044
Novartis Investigative Site
Dehli, New Delhi, 110063
Novartis Investigative Site
Indore, Madhya Pradesh, 452001
Novartis Investigative Site
Mangalore
Novartis Investigative Site
Mumbai, Maharashtra, 400007
Novartis Investigative Site
Mysore, Karnataka, 570004
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

United Kingdom9 sites

Novartis Investigative Site
Bath, BA1 2SR
Novartis Investigative Site
Bath, BA2 3HT
Novartis Investigative Site
Cambridge, United KIngdom, CB7 5JD
Novartis Investigative Site
Chesterfield, S40 4TF
Novartis Investigative Site
Glasgow, G69 7AD
Novartis Investigative Site
Irvine, KA12 0AY
Novartis Investigative Site
Lancashire, FY3 7EN
Novartis Investigative Site
Watford, United Kingdom, WD25 0EA
Novartis Investigative Site
Wellingborough, NN8 4RW

Other trials in United Kingdom

Lithuania6 sites

Novartis Investigative Site
Alytus, LT-62114
Novartis Investigative Site
Kaunas, 44320
Novartis Investigative Site
Klaipėda, 92288
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Vilnius, 06001
Novartis Investigative Site
Vilnius, LT-08661

Other trials in Lithuania

France5 sites

Novartis Investigative Site
Beuvry, France, 62660
Novartis Investigative Site
Ferolles-Attily, France, 77150
Novartis Investigative Site
Montpellier, 34059
Novartis Investigative Site
Nantes, 44000
Novartis Investigative Site
Pessac, 33604

Other trials in France

Hungary5 sites

Novartis Investigative Site
Aszód, 2170
Novartis Investigative Site
Baja, 6500
Novartis Investigative Site
Érd, 2030
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Makó, 6900

Other trials in Hungary

Romania5 sites

Novartis Investigative Site
Brasov, Jud. Brasov, 500118
Novartis Investigative Site
Bucharest, District 1, 011422
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 3, 030303
Novartis Investigative Site
Iași, Jud. Iasi, 700115

Other trials in Romania

Canada4 sites

Novartis Investigative Site
Mirabel, Quebec, J7J 2K8
Novartis Investigative Site
Québec, Quebec, G1G 3Z4
Novartis Investigative Site
Québec, Quebec, G1P 1J6
Novartis Investigative Site
Toronto, Ontario, M3H 5S4

Other trials in Canada

Latvia4 sites

Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Jēkabpils, LV-5201
Novartis Investigative Site
Riga, LV, LV-1038
Novartis Investigative Site
Riga, 1002

Other trials in Latvia

South Korea4 sites

Novartis Investigative Site
Busan, Busan, 602-739
Novartis Investigative Site
Koyang-si, Gyeonggi-do, 410-773
Novartis Investigative Site
Seoul, Seoul, 140-743
Novartis Investigative Site
Seoul, 158-710

Other trials in South Korea

South Africa2 sites

Novartis Investigative Site
Pretoria, 0184
Novartis Investigative Site
Pretoria

Other trials in South Africa

About this study

Official title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: QVA149, Placebo
Keywords: QVA149, COPD, combination bronchodilator
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
capsules for inhalation, delivered by an SDDPI
PlaceboDrug
capsules for inhalation, delivered by an SDDPI

Study groups in NCT01120717
Study group	Role	What they receive
QVA149	Experimental	110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI) Receives: Drug: QVA149
Placebo	Placebo comparator	Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI Receives: Drug: Placebo

What is being measured

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

Number of Participants With Adverse Events, Serious Adverse Events or Death
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Measured: 52 weeks + Follow-up (Up to Day 394)

Secondary outcomes (5)

Pre-dose FEV1
Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.
Measured: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L
Measured: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L
Measured: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.
Measured: 52 weeks
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
Measured: 52 weeks

Timeline

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

Apr 2010Dec 2011

First posted11 May 2010 (estimated)
Study startApr 2010
Primary completionDec 2011
Study completionDec 2011

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 (2)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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 339 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01120717
Sponsor's protocol ID: CQVA149A2307
Other IDs: 2009-013235-38, 2009
Acronym: ENLIGHTEN
Status last verified: Jan 2013
First submitted: 5 May 2010
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.
PubMed 25677679
Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.
PubMed 23867808

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

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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01120717
Acronym / sponsor ID: ENLIGHTEN / CQVA149A2307
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: QVA149, COPD, combination bronchodilator
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 339 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 11 May 2010 (estimated)
Results: Posted 21 Jan 2013

Clinical summary

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

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QVA149	Experimental	Drug: QVA149110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo	Placebo comparator	Drug: PlaceboPlacebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Key exclusion criteria (9 listed)

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions

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
QVA149capsules for inhalation, delivered by an SDDPI	Drug	QVA149
Placebocapsules for inhalation, delivered by an SDDPI	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events, Serious Adverse Events or Death
Time frame: 52 weeks + Follow-up (Up to Day 394)
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.

5 secondary outcomes

Pre-dose FEV1
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks

Results and safety

Results posted to the registry on 21 Jan 2013, 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	226	194
Placebo	113	89

Primary outcome: Number of Participants With Adverse Events, Serious Adverse Events or Death

Time frame: 52 weeks + Follow-up (Up to Day 394). Number. Unit: participants

Measure	QVA149 n = 225	Placebo n = 113
Adverse events	130	64
Serious adverse events	37	12
Death - 1st treatment day to 30d after last dose	4	1
Death - last dose + 30d until end of follow-up	1	0

Population analysed: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected up to Day 394. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149	37 of 225 (16.4%)	82 of 225 (36.4%)	Not reported
Placebo	12 of 113 (10.6%)	41 of 113 (36.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25677679Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.
Derived from this study: PubMed 23867808Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.

Related trials for Chronic Obstructive Pulmonary Disease

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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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

53 sites in 10 countries: 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 53 sites in 10 countries.

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 9 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in India, United Kingdom, Lithuania, France, Hungary and 5 more countries. 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 21 Jan 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?

Number of Participants With Adverse Events, Serious Adverse Events or Death (time frame: 52 weeks + Follow-up (Up to Day 394)). 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 NCT01120717, which also lists 2 linked publications.

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 31 Jan 2013.