Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01727141
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
A Phase 3 study testing QVA149, QAB149 and NVA237 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 143 sites in 8 countries.
Trial summary
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- QVA149, QAB149 and NVA237
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,042 participants
- Where
- 143 sitesin 8 countries
- Study dates
- Nov 2012to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients that have signed informed consent and are >/= 40 years of age.
- Patients with stable COPD according to GOLD 2011.
- Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with an mMRC grade 2 or greater.
Who cannot join
- Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
- Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
- Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
- Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
- Patients who had a COPD exacerbation within 6 weeks prior to screening.
- Patients who have a respiratory tract infection within 4 weeks prior to screening.
Show all 14Show fewer
- Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
- Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
- Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
- Patients with concomitant pulmonary disease.
- Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
- Patients with active pulmonary tuberculosis.
- Patients in the active phase of a pulmonary rehabilitation programme.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
143 sites in 8 countries.
143 sites in 8 countries
United States73 sites
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Ann Arbor, Michigan, 48106-0525
Novartis Investigative Site
Biloxi, Mississippi, 39531
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Brooklyn, New York, 11229
Novartis Investigative Site
Brooklyn, New York, 11234
Novartis Investigative Site
Chattanooga, Tennessee, 37404
Novartis Investigative Site
Chiefland, Florida, 32626
Novartis Investigative Site
Cincinnati, Ohio, 45242
Novartis Investigative Site
Cincinnati, Ohio, 45245
Novartis Investigative Site
Clearwater, Florida, 33765
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Columbus, Ohio, 43213
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigative Site
Dallas, Texas, 75231-4307
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Dublin, Ohio, 43016
Novartis Investigative Site
Edina, Minnesota, 55435
Novartis Investigative Site
El Paso, Texas, 79902
Novartis Investigative Site
Fountain Valley, California, 92708
Novartis Investigative Site
Fridley, Minnesota, 55432
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Great Neck, New York, 11021
Novartis Investigative Site
Greenville, South Carolina, 29615
Novartis Investigative Site
Hendersonville, North Carolina, 28739
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Lynn Haven, Florida, 32444
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Meridian, Idaho, 83642
Novartis Investigative Site
Mesa, Arizona, 85205
Novartis Investigative Site
Minneapolis, Minnesota, 55407
Novartis Investigative Site
Montclair, California, 91763
Novartis Investigative Site
Montgomery, Alabama, 36109
Novartis Investigative Site
Newport News, Virginia, 23606
Novartis Investigative Site
O'Fallon, Illinois, 62269
Novartis Investigative Site
Omaha, Nebraska, 68134
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Orangevale, California, 95662
Novartis Investigative Site
Papillion, Nebraska, 68046
Novartis Investigative Site
Paramount, California, 90723
Novartis Investigative Site
Phoenix, Arizona, 85018
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15221
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15236
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243
Novartis Investigative Site
Richmond, Virginia, 23229
Novartis Investigative Site
Richmond, Virginia, 23294
Novartis Investigative Site
River Forest, Illinois, 60305
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
Rochester, Minnesota, 55901
Novartis Investigative Site
Roseville, California, 95661
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
Sacramento, California, 95823
Novartis Investigative Site
Sacramento, California, 95825
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
San Antonio, Texas, 78205
Novartis Investigative Site
San Diego, California, 92117-4946
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigative Site
Seattle, Washington
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tipton, Pennsylvania, 16684
Novartis Investigative Site
Torrance, California, 90502
Novartis Investigative Site
Union, South Carolina, 29379
Novartis Investigative Site
Waltham, Massachusetts, 02154
Novartis Investigative Site
Waterbury, Connecticut, 06708
Novartis Investigative Site
Wheat Ridge, Colorado, 80033
Canada21 sites
Novartis Investigative Site
Burlington, Ontario, L7N 3V2
Novartis Investigative Site
Courtice, Ontario, L1E 3C3
Novartis Investigative Site
Gatineau, Quebec, J8Y 6S8
Novartis Investigative Site
Montreal, Quebec, H3G 1L5
Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Novartis Investigative Site
Pointe-Claire, Quebec, H9R 3j1
Novartis Investigative Site
Québec, Quebec, G1G 3Y8
Novartis Investigative Site
Québec, Quebec, G3K 2P8
Novartis Investigative Site
Québec, Quebec, GIV 4M6
Novartis Investigative Site
Saint Romuald, Quebec, G6W 5M6
Novartis Investigative Site
Saint-Charles-Borromée, Quebec, J6E 2B4
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Sainte-Foy, Quebec, G1W 4R4
Novartis Investigative Site
Sherbrooke, Quebec, J1J 2G2
Novartis Investigative Site
Toronto, Ontario, M5G1N8
Novartis Investigative Site
Toronto, Ontario, M5T 3A9
Novartis Investigative Site
Toronto, Ontario, M6H 3M2
Novartis Investigative Site
Trois-Rivières, Quebec, G8T 7A1
Novartis Investigative Site
Vancouver, British Columbia, V5Z 3J5
Novartis Investigative Site
Victoriaville, Quebec, G6P 6P6
Novartis Investigative Site
Windsor, Ontario, N8X 5A6
Ukraine18 sites
Novartis Investigative Site
Dnipropetrovsk, Ukraine, 49074
Novartis Investigative Site
Dnipropetrovsk, 49027
Novartis Investigative Site
Donetsk, 83099
Novartis Investigative Site
Kharkiv, Ukraine, 61039
Novartis Investigative Site
Kharkiv, Ukraine, 61124
Novartis Investigative Site
Kharkiv, 61172
Novartis Investigative Site
Kiev, 02232
Novartis Investigative Site
Kiev, 04050
Novartis Investigative Site
Kyiv, 03680
Novartis Investigative Site
Kyiv, 04050
Novartis Investigative Site
Luhansk, 91055
Novartis Investigative Site
Lviv
Novartis Investigative Site
Poltava, 36024
Novartis Investigative Site
Vinnytsia, 21001
Novartis Investigative Site
Vinnytsia, 21018
Novartis Investigative Site
Zaporizhzhya, 69104
Novartis Investigative Site
Zaporizhzhya, 69600
Novartis Investigative Site
Zhytomyr, 10002
Spain12 sites
Novartis Investigative Site
Barakaldo, Vizcaya, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Cáceres, Extremadura, 10003
Novartis Investigative Site
Gijón, Principality of Asturias, 33290
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Mérida, Extremadura, 06800
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120
Novartis Investigative Site
Ponferrada, Castille and León, 24400
Novartis Investigative Site
Salt, Catalonia, 17190
Novartis Investigative Site
Sant Boi de Llobregat, Catalonia, 08830
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Valladolid, Castille and León, 47011
Romania9 sites
Novartis Investigative Site
Arad, 310013
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 1, 11475
Novartis Investigative Site
Bucharest, District 3, 030303
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, 050159
Novartis Investigative Site
Craiova, Dolj, 200515
Novartis Investigative Site
Deva, 330162
Novartis Investigative Site
Iași, Jud. Iasi, 700115
Philippines4 sites
Novartis Investigative Site
Bulacan, Philippines, 3020
Novartis Investigative Site
Manila, Philippines, 1000
Novartis Investigative Site
Quezon City, 1100
Novartis Investigative Site
San Pablo City, Laguna, 4000
Poland3 sites
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Tarnów, 33-100
Novartis Investigative Site
Wroclaw, 51-162
Vietnam3 sites
Novartis Investigative Site
Hanoi
Novartis Investigative Site
Ho Chi Minh City, Vietnam
Novartis Investigative Site
Ho Chi Minh City
About this study
Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
Read the detailed description
NOTE: Detailed Description: data not entered
- Being tested
- QVA149, QAB149, NVA237, Placebo
- Keywords
- COPD, QVA149
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVA149Drug
QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QAB149Drug
QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
NVA237Drug
NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
PlaceboDrug
Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
| Study group | Role | What they receive |
|---|---|---|
| QVA149 | Experimental | 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI) Receives: Drug: QVA149 |
| QAB149 | Active comparator | 27.5 ug b.i.d. Receives: Drug: QAB149 |
| NVA237 | Active comparator | 12.5 ug b.i.d. Receives: Drug: NVA237 |
| Placebo | Placebo comparator | b.i.d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.
Measured: baseline (BL), 12 Weeks
Secondary outcomes (10)
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement.
Measured: BL, 12 Weeks
Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score
Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
Measured: 12 weeks
Change From Baseline in Trough FEV1
Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.
Measured: BL, day 2, day 86
Change From Baseline in Pre-dose Trough FEV1
Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.
Measured: BL, day 85
Change From Baseline in FEV1
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Measured: BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min
Change From Baseline in FVC
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Measured: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min
Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.
Measured: BL, day 1, week 12
Transitional Dyspnea Index (TDI) Focal Score
The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. 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.
Measured: BL, 12 weeks
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.
Measured: BL, 12 Weeks
Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Measured: BL, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727141
- Sponsor's protocol ID
- CQVA149A2336
- Status last verified
- Mar 2016
- First submitted
- 12 Nov 2012
- Last updated
- 29 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.
PubMed 31539467Mahler DA, Kerwin E, Ayers T, FowlerTaylor A, Maitra S, Thach C, Lloyd M, Patalano F, Banerji D. FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1068-79. doi: 10.1164/rccm.201505-1048OC.
PubMed 26177074
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
- ClinicalTrials.gov ID
- NCT01727141
- Acronym / sponsor ID
- CQVA149A2336
- Keywords
- COPD, QVA149
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
Detailed description
NOTE: Detailed Description: data not entered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QVA149 | Experimental | Drug: QVA14927.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI) |
| QAB149 | Active comparator | Drug: QAB14927.5 ug b.i.d. |
| NVA237 | Active comparator | Drug: NVA23712.5 ug b.i.d. |
| Placebo | Placebo comparator | Drug: Placebob.i.d |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients that have signed informed consent and are >/= 40 years of age.
- Patients with stable COPD according to GOLD 2011.
- Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with an mMRC grade 2 or greater.
Key exclusion criteria (14 listed)
- Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
- Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
- Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
- Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
- Patients who had a COPD exacerbation within 6 weeks prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QVA149QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI | Drug | QVA149 |
| QAB149QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. | Drug | QAB149 |
| NVA237NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. | Drug | NVA237 |
| PlaceboPlacebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. | Drug | Placebo |
Primary outcome
Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))
Time frame: baseline (BL), 12 Weeks
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.
10 secondary outcomes
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: BL, 12 Weeks
Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score
Time frame: 12 weeks
Change From Baseline in Trough FEV1
Time frame: BL, day 2, day 86
Change From Baseline in Pre-dose Trough FEV1
Time frame: BL, day 85
Change From Baseline in FEV1
Time frame: BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min
Change From Baseline in FVC
Time frame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min
Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)
Time frame: BL, day 1, week 12
Transitional Dyspnea Index (TDI) Focal Score
Time frame: BL, 12 weeks
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
Time frame: BL, 12 Weeks
Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score
Time frame: BL, 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31539467Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.
- Derived from this study: PubMed 26177074Mahler DA, Kerwin E, Ayers T, FowlerTaylor A, Maitra S, Thach C, Lloyd M, Patalano F, Banerji D. FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1068-79. doi: 10.1164/rccm.201505-1048OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
143 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVA149, QAB149 and NVA237 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 143 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 143 sites in United States, Canada, Ukraine, Spain, Romania and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (time frame: baseline (BL), 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727141, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.