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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02516592
Registration number
NCT02516592
Ethics application status
Date submitted
4/08/2015
Date registered
6/08/2015
Date last updated
21/03/2019
Titles & IDs
Public title
Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
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Scientific 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
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Secondary ID [1]
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CQVA149A3405
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Universal Trial Number (UTN)
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Trial acronym
FLASH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QVA149 110/50 micrograms
Treatment: Drugs - Salmeterol/fluticasone 50/500 microgrammes
Experimental: QVA149 110/50 micrograms - QVA149 110/50 micrograms o.d. Capsules for inhalation
Active comparator: salmeterol/fluticasone 50/500 micrograms - salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Treatment: Drugs: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
Treatment: Drugs: Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Trough Pre-dose FEV1 in Both Arms
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, week 12
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Secondary outcome [1]
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Transitional Dyspnea Index (TDI) Focal Score
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, week 12
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Secondary outcome [2]
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Change From Baseline in FVC (Forced Vital Capacity)
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Assessment method [2]
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Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
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Timepoint [2]
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week 12
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Secondary outcome [3]
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Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)
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Assessment method [3]
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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.
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Timepoint [3]
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week 12
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Secondary outcome [4]
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Change From Baseline in Mean Daily Use of Rescue Medication
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Assessment method [4]
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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.
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Timepoint [4]
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over 12 weeks
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Eligibility
Key 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
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Minimum age
40
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/05/2017
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Sample size
Target
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Accrual to date
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Final
500
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,South AustrailiaSA,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Coffs Harbour
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Novartis Investigative Site - Drummoyne
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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2047 - Drummoyne
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2145 - Westmead
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4870 - Cairns
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5041 - Daw Park
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5042 - Bedford Park
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5064 - Glen Osmond
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
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Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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Fayoum
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Gujarat
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India
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New Delhi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief 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. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.
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Trial website
https://clinicaltrials.gov/study/NCT02516592
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT02516592/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT02516592/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02516592
Download to PDF