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Chronic Obstructive Pulmonary DiseasePhase 3NCT01860066

A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

A Phase 3 study testing QVA149 and fluticasone/salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 31 sites in 5 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation. Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
QVA149 and fluticasone/salmeterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
31 sitesin 5 countries
Study dates
Dec 2013to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Inclusion Criteria: - Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

India8 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 008

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 002

  • Novartis Investigative Site

    Faridabad, Haryana, 121 001

  • Novartis Investigative Site

    Guntur, Andhra Pradesh, 522 001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302004

  • Novartis Investigative Site

    Karamsad, India, 388225

  • Novartis Investigative Site

    Nagpur, Maharashtra, 400 012

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

Other trials in India

Argentina7 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, 1425

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1115AAB

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires

  • Novartis Investigative Site

    Mendoza, Mendoza Province, 5500

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500CBA

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Czechia7 sites

  • Novartis Investigative Site

    Cvikov, Czech Republic, 471 54

  • Novartis Investigative Site

    Jindřichův Hradec, Czech Republic, 377 01

  • Novartis Investigative Site

    Karlovy Vary, Czech Republic, 360 66

  • Novartis Investigative Site

    Kuřim, Czech Republic, 664 34

  • Novartis Investigative Site

    Kyjov, CZE, 697 70

  • Novartis Investigative Site

    Pardubice, Czech Republic, 530 09

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

Other trials in Czechia

Belgium6 sites

  • Novartis Investigative Site

    Antwerp, 2060

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Gilly, 6060

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Jambes, 5100

Other trials in Belgium

Colombia3 sites

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Florida Blanca

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

About this study

Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation

Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.

Being tested
QVA149, fluticasone/salmeterol
Keywords
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 via inhaler twice a day

  • fluticasone/salmeterolDrug

    fluticasone/salmeterol via inhaler twice a day

Study groups in NCT01860066
Study groupRoleWhat they receive
QVA149ExperimentalQVA149 study medication kit will contain blister strips and a unique inhaler. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Receives: Drug: QVA149
fluticasone/salmeterolActive comparatorFluticasone/salmeterol study medication kit will contain an inhaler in the manufacturer's device. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Receives: Drug: fluticasone/salmeterol

What is being measured

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

  1. Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment

    Area under the curve (AUC) 0-12 hours for Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours

    Measured: 12 weeks

Secondary outcomes (9)

  1. Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment

    Spiromtery testing conducted according to internationally accepted standards. 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 trough FEV1 will be will be defined as the mean from repeat measurements at Day 1 and week 12

    Measured: Day 1 and Week 12

  2. Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose

    Spirometry testing conducted accorded to internationally accepted standards. Peak FEV1 defined as the maximum FEV1 during the first 4 hours post dosing. The Peak FEV1 will be defined as the mean from repeat measurements at Day 1 and week 12.

    Measured: Day 1 and Week 12

  3. Area under the curve (AUC) 0-4 hours for FEV1

    Area under the curve (AUC) 0-4 hours for Forced Expiratory Volume in 1 second (FEV1) at Day 1 and week 12. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours.

    Measured: Day 1 and Week 12

  4. Transition Dyspnea Index (TDI) Focal Score

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline; negative scores indicate deterioration. A TDI focal score of 1 unit is considered to be a minimal clinically important difference (MCID) from baseline.

    Measured: Week 12

  5. Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)

    SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from baseline in total score will be assessed.

    Measured: Week 12

  6. Change from baseline in daily number of puffs of rescue medication

    Number of puffs of rescue medication in previous 12 hours is recorded in Patient Diary twice daily. The total number of puffs of rescue medication per day (daily use) over the active treatment period will be used to derive the mean daily number of puffs of rescue medication taken by the patient.

    Measured: Week 12

  7. Daily symptoms reported by patient

    Patient's daily symptoms will be recorded twice daily using a patient diary. Mean daily total symptom score, mean morning and evening symptom score for each patient will be calculated over the 12 week study period.

    Measured: Week 12

  8. COPD assessment (CAT) test

    COPD assessment test (CAT) contains 8 questions regarding patient symptoms. Patient will complete questions using a 6 point scale and total score out of a possible score of 40 will be summed and reported.

    Measured: Week 12

  9. Safety and tolerability

    All adverse events and serious adverse events (SAEs) will be reported.

    Measured: Over 12 weeks

Timeline

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

  1. First posted22 May 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionSep 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860066
Sponsor's protocol ID
CQVA149A2328
Status last verified
Nov 2013
First submitted
15 Apr 2013
Last updated
11 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149 and fluticasone/salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 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 31 sites in India, Argentina, Czechia, Belgium, Colombia. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment (time frame: 12 weeks). 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 NCT01860066.

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 11 Nov 2013.

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