Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
NCT ID: NCT02516592
Last Updated: 2019-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2015-10-13
2017-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
salmeterol/fluticasone 50/500 micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
Interventions
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QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Coffs Harbour, New South Wales, Australia
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Drummoyne, New South Wales, Australia
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Westmead, New South Wales, Australia
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Cairns, Queensland, Australia
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Daw Park, South Austrailia, Australia
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Bedford Park, South Australia, Australia
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Glen Osmond, South Australia, Australia
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Murdoch, Western Australia, Australia
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Al Fayyum, , Egypt
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Alexandria, , Egypt
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Cairo, , Egypt
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Ahmedabad, Gujarat, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Mohali, Punjab, India
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Coimbatore, Tamil Nadu, India
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New Delhi, , India
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Sefad, , Israel
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Tel Giborim, Holon, , Israel
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El Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Hazmiyeh, , Lebanon
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Saida, , Lebanon
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Kota Bharu, Kelantan, Malaysia
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Kuantan, Pahang, Malaysia
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Taiping, Perak, Malaysia
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Kuching, Sarawak, Malaysia
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Miri, Sarawak, Malaysia
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Kuala Lumpur, , Malaysia
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Lipa City, Batangas, Philippines
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Bulacan, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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San Pablo City, Laguna, , Philippines
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Riyadh, SAU, Saudi Arabia
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Jeddah, , Saudi Arabia
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Cape Town, , South Africa
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Durban, , South Africa
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Gatesville, , South Africa
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Johannesburg, , South Africa
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Phoenix, , South Africa
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Kaoshiung, , Taiwan
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Linkou District, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Adana, , Turkey (Türkiye)
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Aydin, , Turkey (Türkiye)
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Erzurum, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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Yenisehir/Izmir, , Turkey (Türkiye)
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CQVA149A3405
Identifier Type: -
Identifier Source: org_study_id
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