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

NCT02516592 | Completed Phase 4 Results

• 1 other identifier: CQVA149A3405
• Study Type: interventional
• Target: 500
• Locations: 11 countries
• Sites: 64

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (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).

  Baseline, week 12

Secondary Outcomes (4)

• Transitional Dyspnea Index (TDI) Focal Score

  Baseline, week 12

• Change From Baseline in FVC (Forced Vital Capacity)

  week 12

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

  week 12

• Change From Baseline in Mean Daily Use of Rescue Medication

  over 12 weeks

Study Arms (2)

QVA149 110/50 micrograms

EXPERIMENTAL

QVA149 110/50 micrograms o.d. Capsules for inhalation

Drug: QVA149 110/50 micrograms

salmeterol/fluticasone 50/500 micrograms

ACTIVE COMPARATOR

salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder

Drug: Salmeterol/fluticasone 50/500 microgrammes

Interventions

QVA149 110/50 micrograms DRUG

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

QVA149 110/50 micrograms

Salmeterol/fluticasone 50/500 microgrammes DRUG

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

salmeterol/fluticasone 50/500 micrograms

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (64)

Novartis Investigative Site

Coffs Harbour, New South Wales, 2450, Australia

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Drummoyne, New South Wales, 2047, Australia

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Westmead, New South Wales, 2145, Australia

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Cairns, Queensland, 4870, Australia

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Daw Park, South Austrailia, 5041, Australia

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Bedford Park, South Australia, 5042, Australia

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Glen Osmond, South Australia, 5064, Australia

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Murdoch, Western Australia, 6150, Australia

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Al Fayyum, 63514, Egypt

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Alexandria, 21131, Egypt

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Cairo, 11566, Egypt

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Ahmedabad, Gujarat, 380 008, India

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Nagpur, Maharashtra, 400 012, India

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Nagpur, Maharashtra, 440010, India

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Mohali, Punjab, 160 062, India

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Coimbatore, Tamil Nadu, 641 045, India

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New Delhi, 110029, India

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Ashkelon, 78278, Israel

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Beersheba, 84101, Israel

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Haifa, 3525408, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 7610001, Israel

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Sefad, 13100, Israel

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Tel Giborim, Holon, 58100, Israel

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El Chouf, LBN, 1503201002, Lebanon

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Beirut, 1107 2020, Lebanon

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Beirut, 166378, Lebanon

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Beirut, 6301, Lebanon

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El Achrafiyé, 166830, Lebanon

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Hazmiyeh, 470, Lebanon

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Saida, 652, Lebanon

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Kota Bharu, Kelantan, 15586, Malaysia

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Kuantan, Pahang, 25100, Malaysia

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Taiping, Perak, 34000, Malaysia

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Kuching, Sarawak, 93586, Malaysia

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Miri, Sarawak, 98000, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Lipa City, Batangas, 4217, Philippines

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Bulacan, 3020, Philippines

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Manila, 1000, Philippines

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Quezon City, 1100, Philippines

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San Pablo City, Laguna, 4000, Philippines

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Riyadh, SAU, 11525, Saudi Arabia

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Jeddah, 21423, Saudi Arabia

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Cape Town, 7500, South Africa

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Durban, 4001, South Africa

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Gatesville, 7764, South Africa

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Johannesburg, 2193, South Africa

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Phoenix, 4068, South Africa

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Kaoshiung, 83301, Taiwan

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Linkou District, Taiwan

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New Taipei City, 22060, Taiwan

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Taichung, 40705, Taiwan

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Adana, 01330, Turkey (Türkiye)

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Aydin, 09100, Turkey (Türkiye)

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Erzurum, 25240, Turkey (Türkiye)

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Istanbul, 34854, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Konya, 42080, Turkey (Türkiye)

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Mersin, 33079, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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Yenisehir/Izmir, 35110, Turkey (Türkiye)

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Related Publications (1)

• 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.

  PMID: 30074294 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 6, 2015
• Study Start: October 13, 2015
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-12

Locations

TW (4); MY (6); TU (9); IL (9); LE (7); SA (2); AU (8); EG (3); PH (5); IN (6); ZA (5)