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

December 11, 2018 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Novartis Investigative Site
      • Drummoyne, New South Wales, Australia, 2047
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Novartis Investigative Site
    • South Austrailia
      • Daw Park, South Austrailia, Australia, 5041
        • Novartis Investigative Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Novartis Investigative Site
      • Glen Osmond, South Australia, Australia, 5064
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Novartis Investigative Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novartis Investigative Site
      • Cairo, Egypt, 11566
        • Novartis Investigative Site
      • Fayoum, Egypt, 63514
        • Novartis Investigative Site
  • India
      • New Delhi, India, 110029
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 008
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 400 012
        • Novartis Investigative Site
      • Nagpur, Maharashtra, India, 440010
        • Novartis Investigative Site
    • Punjab
      • Mohali, Punjab, India, 160 062
        • Novartis Investigative Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 045
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Be'er Sheva, Israel, 84101
        • Novartis Investigative Site
      • Haifa, Israel, 3525408
        • Novartis Investigative Site
      • Jerusalem, Israel, 91120
        • Novartis Investigative Site
      • Jerusalem, Israel, 91031
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Rehovot, Israel, 7610001
        • Novartis Investigative Site
      • Sefad, Israel, 13100
        • Novartis Investigative Site
      • Tel Giborim, Holon, Israel, 58100
        • Novartis Investigative Site
  • Lebanon
      • Ashrafieh, Lebanon, 166830
        • Novartis Investigative Site
      • Beirut, Lebanon, 1107 2020
        • Novartis Investigative Site
      • Beirut, Lebanon, 6301
        • Novartis Investigative Site
      • Beirut, Lebanon, 166378
        • Novartis Investigative Site
      • Hazmieh, Lebanon, 470
        • Novartis Investigative Site
      • Saida, Lebanon, 652
        • Novartis Investigative Site
    • LBN
      • El Chouf, LBN, Lebanon, 1503201002
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Novartis Investigative Site
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Novartis Investigative Site
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Novartis Investigative Site
      • Miri, Sarawak, Malaysia, 98000
        • Novartis Investigative Site
  • Philippines
      • Bulacan, Philippines, 3020
        • Novartis Investigative Site
      • Manila, Philippines, 1000
        • Novartis Investigative Site
      • Quezon City, Philippines, 1100
        • Novartis Investigative Site
      • San Pablo City, Laguna, Philippines, 4000
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
        • Novartis Investigative Site
    • SAU
      • Riyadh, SAU, Saudi Arabia, 11525
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Novartis Investigative Site
      • Durban, South Africa, 4001
        • Novartis Investigative Site
      • Gatesville, South Africa, 7764
        • Novartis Investigative Site
      • Johannesburg, South Africa, 2193
        • Novartis Investigative Site
      • Phoenix, South Africa, 4068
        • Novartis Investigative Site
  • Taiwan
      • Kaoshiung, Taiwan, 83301
        • Novartis Investigative Site
      • Lin-Kou, Taiwan
        • Novartis Investigative Site
      • New Taipei, Taiwan, 22060
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
  • Turkey
      • Adana, Turkey, 01330
        • Novartis Investigative Site
      • Aydin, Turkey, 09100
        • Novartis Investigative Site
      • Erzurum, Turkey, 25240
        • Novartis Investigative Site
      • Istanbul, Turkey, 34854
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Konya, Turkey, 42080
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
      • Trabzon, Turkey, 61080
        • Novartis Investigative Site
      • Yenisehir/Izmir, Turkey, 35110
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
Drug: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
Active Comparator: salmeterol/fluticasone 50/500 micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Drug: Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Pre-dose FEV1 in Both Arms
Time Frame: Baseline, week 12
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).
Baseline, week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transitional Dyspnea Index (TDI) Focal Score
Time Frame: Baseline, week 12
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.
Baseline, week 12
Change From Baseline in FVC (Forced Vital Capacity)
Time Frame: week 12
Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
week 12
Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)
Time Frame: week 12
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.
week 12
Change From Baseline in Mean Daily Use of Rescue Medication
Time Frame: over 12 weeks
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.
over 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQVA149A3405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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