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

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ClinicalTrials.gov Identifier: NCT02516592
Recruitment Status : Completed
First Posted : August 6, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
COPD Drug: QVA149 110/50 micrograms Drug: Salmeterol/fluticasone 50/500 microgrammes Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516592


  Show 64 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] June 13, 2017
Study Protocol  [PDF] June 17, 2015


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02516592     History of Changes
Other Study ID Numbers: CQVA149A3405
First Posted: August 6, 2015    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: December 2018

Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Glycopyrrolate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents