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COPDPhase 4FLASHNCT02516592

Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort

A Phase 4 study testing QVA149 110/50 micrograms and Salmeterol/fluticasone 50/500 microgrammes in people with COPD, run by Novartis Pharmaceuticals at 64 sites in 11 countries.

Completed

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

Official record
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Trial summary

This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
QVA149 110/50 micrograms and Salmeterol/fluticasone 50/500 microgrammes
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
64 sitesin 11 countries
Study dates
13 Oct 2015to 4 May 2017
Phase
Phase 4
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

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female ≥ 40 years
  • Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at visit 1
  • Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1
  • Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to visit 1
  • Documented CAT score of ≥ 10 at Visit 1 and 2

Who cannot join

  • Treatment with any LAMA in the 2 weeks prior to visit 1
  • Presence of any contraindication, warning, precaution, hypersensitivity in the approved prescribing information for salmeterol/fluticasone
  • Prior or current diagnosis of asthma
  • More than one COPD exacerbation requiring treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the year prior to Visit 1
  • Patients who developed a COPD exacerbation of any severity within the 6 weeks before the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
  • Respiratory tract infection within 4 weeks prior to Visit 1
Show all 9Show fewer
  • Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks after resolution of the infection
  • Requiring oxygen therapy prescribed for >12 hours per day
  • Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years

Trial locations and contacts

64 sites in 11 countries.

64 sites in 11 countries

Israel9 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 7610001

  • Novartis Investigative Site

    Sefad, 13100

  • Novartis Investigative Site

    Tel Giborim, Holon, 58100

Other trials in Israel

Turkey (Türkiye)9 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Aydin, 09100

  • Novartis Investigative Site

    Erzurum, 25240

  • Novartis Investigative Site

    Istanbul, 34854

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Konya, 42080

  • Novartis Investigative Site

    Mersin, 33079

  • Novartis Investigative Site

    Trabzon, 61080

  • Novartis Investigative Site

    Yenisehir/Izmir, 35110

Other trials in Turkey (Türkiye)

Australia8 sites

  • Novartis Investigative Site

    Bedford Park, South Australia, 5042

  • Novartis Investigative Site

    Cairns, Queensland, 4870

  • Novartis Investigative Site

    Coffs Harbour, New South Wales, 2450

  • Novartis Investigative Site

    Daw Park, South Austrailia, 5041

  • Novartis Investigative Site

    Drummoyne, New South Wales, 2047

  • Novartis Investigative Site

    Glen Osmond, South Australia, 5064

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

Other trials in Australia

Lebanon7 sites

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    Beirut, 6301

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    El Chouf, LBN, 1503201002

  • Novartis Investigative Site

    Hazmiyeh, 470

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

India6 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 008

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045

  • Novartis Investigative Site

    Mohali, Punjab, 160 062

  • Novartis Investigative Site

    Nagpur, Maharashtra, 400 012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    New Delhi, 110029

Other trials in India

Malaysia6 sites

  • Novartis Investigative Site

    Kota Bharu, Kelantan, 15586

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Kuantan, Pahang, 25100

  • Novartis Investigative Site

    Kuching, Sarawak, 93586

  • Novartis Investigative Site

    Miri, Sarawak, 98000

  • Novartis Investigative Site

    Taiping, Perak, 34000

Other trials in Malaysia

Philippines5 sites

  • Novartis Investigative Site

    Bulacan, 3020

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Manila, 1000

  • Novartis Investigative Site

    Quezon City, 1100

  • Novartis Investigative Site

    San Pablo City, Laguna, 4000

Other trials in Philippines

South Africa5 sites

  • Novartis Investigative Site

    Cape Town, 7500

  • Novartis Investigative Site

    Durban, 4001

  • Novartis Investigative Site

    Gatesville, 7764

  • Novartis Investigative Site

    Johannesburg, 2193

  • Novartis Investigative Site

    Phoenix, 4068

Other trials in South Africa

Taiwan4 sites

  • Novartis Investigative Site

    Kaoshiung, 83301

  • Novartis Investigative Site

    Linkou District

  • Novartis Investigative Site

    New Taipei City, 22060

  • Novartis Investigative Site

    Taichung, 40705

Other trials in Taiwan

Egypt3 sites

  • Novartis Investigative Site

    Al Fayyum, 63514

  • Novartis Investigative Site

    Alexandria, 21131

  • Novartis Investigative Site

    Cairo, 11566

Other trials in Egypt

Saudi Arabia2 sites

  • Novartis Investigative Site

    Jeddah, 21423

  • Novartis Investigative Site

    Riyadh, SAU, 11525

Other trials in Saudi Arabia

About this study

Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients

This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.

Conditions
COPD
Being tested
QVA149 110/50 micrograms, Salmeterol/fluticasone 50/500 microgrammes
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.

  • QVA149 110/50 microgramsDrug

    QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)

  • Salmeterol/fluticasone 50/500 microgrammesDrug

    Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device

Study groups in NCT02516592
Study groupRoleWhat they receive
QVA149 110/50 microgramsExperimentalQVA149 110/50 micrograms o.d. Capsules for inhalation
Receives: Drug: QVA149 110/50 micrograms
salmeterol/fluticasone 50/500 microgramsActive comparatorsalmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Receives: Drug: Salmeterol/fluticasone 50/500 microgrammes

What is being measured

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

  1. Change From Baseline in Trough Pre-dose FEV1 in Both Arms

    Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).

    Measured: Baseline, week 12

Secondary outcomes (4)

  1. Transitional Dyspnea Index (TDI) Focal Score

    Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.

    Measured: Baseline, week 12

  2. Change From Baseline in FVC (Forced Vital Capacity)

    Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1

    Measured: week 12

  3. Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)

    The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.

    Measured: week 12

  4. Change From Baseline in Mean Daily Use of Rescue Medication

    Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.

    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 posted6 Aug 2015 (estimated)
  2. Study start13 Oct 2015
  3. Primary completion4 May 2017
  4. Study completion4 May 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516592
Sponsor's protocol ID
CQVA149A3405
Acronym
FLASH
Status last verified
Dec 2018
First submitted
4 Aug 2015
Last updated
21 Mar 2019
Data monitoring committee
No

Publications

  • Frith PA, Ashmawi S, Krishnamurthy S, Gurgun A, Hristoskova S, Pilipovic V, Hamann AM, Backer A, Olsson P, Kostikas K, Diaz DV; FLASH Investigators. Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial. Respirology. 2018 Dec;23(12):1152-1159. doi: 10.1111/resp.13374. Epub 2018 Aug 3.

    PubMed 30074294

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing QVA149 110/50 micrograms and Salmeterol/fluticasone 50/500 microgrammes in people with COPD, run by Novartis Pharmaceuticals at 64 sites in 11 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 6 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Israel, Turkey (Türkiye), Australia, Lebanon, India and 6 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Mar 2019). 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 Trough Pre-dose FEV1 in Both Arms (time frame: Baseline, week 12). 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 NCT02516592, 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 21 Mar 2019.

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