Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02554786 | A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma | PHASE3 | COMPLETED | 2,216 | — | — | Dec 29, 2015 | Jun 28, 2019 | Mar 5, 2020 | 388 | United States, Bulgaria +22 |
| NCT01079130 | Efficacy and Safety of Different Doses of Indacaterol | PHASE3 | COMPLETED | 511 | — | — | Feb 1, 2010 | - | Aug 19, 2011 | 71 | United States |
| NCT03257995 | Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. | PHASE2 | COMPLETED | 54 | — | — | Sep 5, 2017 | Jan 18, 2018 | Jan 5, 2021 | 6 | United States |
| NCT01959412 | Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma | PHASE2 | COMPLETED | 91 | — | — | Nov 1, 2013 | Mar 1, 2014 | May 6, 2015 | 12 | United States |
| NCT01609478 | Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma | PHASE2 | COMPLETED | 335 | — | — | Aug 1, 2012 | Jul 1, 2013 | Jan 27, 2015 | 96 | Bulgaria, Canada +6 |
| NCT00605306 | Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma | PHASE2 | COMPLETED | 28 | — | — | Jan 1, 2008 | Apr 1, 2008 | Apr 22, 2013 | 3 | France |
| NCT00545272 | A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma | PHASE2 | COMPLETED | 392 | — | — | Oct 1, 2007 | Apr 1, 2008 | Jan 18, 2013 | 60 | Belgium, Czechia +8 |
| NCT00556673 | Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma | PHASE2 | COMPLETED | 31 | — | — | Oct 1, 2007 | Apr 1, 2008 | Apr 22, 2013 | 2 | France, Germany |
| NCT00403637 | Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma | PHASE2 | COMPLETED | 45 | — | — | Nov 1, 2006 | Feb 1, 2007 | Nov 18, 2016 | 5 | United States |
| NCT00403754 | Dose Ranging Study for Indacaterol in Japanese Asthma Patients | PHASE2 | COMPLETED | 41 | — | — | Nov 1, 2006 | Nov 1, 2007 | Aug 17, 2011 | 8 | Japan |
| NCT00624702 | Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma | PHASE1 | COMPLETED | 98 | — | — | Feb 1, 2008 | Sep 1, 2008 | Dec 19, 2020 | 2 | Canada |
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
| Arm | Type | Description |
|---|---|---|
| QMF149 150/160 µg | EXPERIMENTAL | QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered once daily (o.d) via Concept1 inhaler in the evening. |
| QMF149 150/320 µg | EXPERIMENTAL | QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d via Concept1 inhaler in the evening. |
| MF 400 µg | ACTIVE_COMPARATOR | Mometasone furoate (MF) 400 μg was delivered o.d via Twisthaler® in the evening |
| Salmeterol /fluticasone 50/500 μg | ACTIVE_COMPARATOR | Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. |
| MF 800 μg | ACTIVE_COMPARATOR | MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. |
| Indacaterol 18.75 µg | EXPERIMENTAL | Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Indacaterol 37.5 µg | EXPERIMENTAL | Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Indacaterol 75 µg | EXPERIMENTAL | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Indacaterol 150 µg | EXPERIMENTAL | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Salmeterol | ACTIVE_COMPARATOR | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Placebo | PLACEBO_COMPARATOR | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Sequence 1 | EXPERIMENTAL | A-B-C |
| Sequence 2 | EXPERIMENTAL | B-C-A |
| Sequence 3 | EXPERIMENTAL | C-A-B |
| Sequence 4 | EXPERIMENTAL | A-C-B |
| Sequence 5 | EXPERIMENTAL | B-A-C |
| Sequence 6 | EXPERIMENTAL | C-B-A |
| Treatment Period Sequence 1 | EXPERIMENTAL | Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening |
| Treatment Period Sequence 2 | EXPERIMENTAL | Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening |
| Treatment Period Sequence 3 | EXPERIMENTAL | Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening |
| Treatment Sequence Period 4 | EXPERIMENTAL | Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening |
| Treatment Period Sequence 5 | EXPERIMENTAL | Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening |
| Treatment Period Sequence 6 | EXPERIMENTAL | Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening |
| indacaterol acetate 75 µg | EXPERIMENTAL | indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
| indacaterol acetate 150 µg | EXPERIMENTAL | indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
| indacaterol maleate/mometasone furoate | EXPERIMENTAL | Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. |
| indacaterol 62.5 μg | EXPERIMENTAL | Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| indacaterol 125 μg | EXPERIMENTAL | Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| indacaterol 250 μg | EXPERIMENTAL | Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| indacaterol 500 μg | EXPERIMENTAL | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| formoterol | ACTIVE_COMPARATOR | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| Indacaterol/mometasone - Placebo | EXPERIMENTAL | In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. |
| Placebo - indacaterol/mometasone | EXPERIMENTAL | In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. |
| Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol | EXPERIMENTAL | In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study. |
| Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol | EXPERIMENTAL | In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study. |
| Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol | EXPERIMENTAL | In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study. |
| Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol | EXPERIMENTAL | In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study. |
| 1 | ACTIVE_COMPARATOR | Active Comparator 1 different salt formulation of Indacaterol. |
| 2 | ACTIVE_COMPARATOR | Active Comparator 2 different salt formulation of Indacaterol. |
| 3 | ACTIVE_COMPARATOR | Active Comparator 3 different salt formulation of Indacaterol. |
| 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Indacaterol acetate/Mometasone furoate | DRUG | - |
| Mometasone furoate | DRUG | - |
| Salmeterol xinafoate/fluticasone propionate | DRUG | - |
| Indacaterol | DRUG | Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme. |
| Salmeterol | DRUG | 50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. |
| Placebo to Indacaterol | DRUG | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI. |
| Placebo to Salmeterol | DRUG | Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI). |
| Indacaterol maleate | DRUG | 150 μg via Concept1 device |
| Indacaterol acetate | DRUG | 150 μg via Concept1 device |
| Placebo | DRUG | Capsule containing no active ingredients delivered via Concept1 device |
| Indacaterol 27.5 mcg | DRUG | indacaterol 27.5 mcg twice daily inhaled once via inhaler |
| Indacaterol 37.5 | DRUG | Indacaterol 37.5 mcg once daily, inhaled once via inhaler |
| Indacaterol 55 mcg | DRUG | Indacaterol 55 mcg once daily, inhaled once via inhaler |
| Indacaterol 75 mcg | DRUG | Indacaterol 75 mcg once daily, inhaled once via inhaler |
| Indacaterol 150 mcg | DRUG | Indacaterol 150 mcg once daily, inhaled once via inhaler |
| indacaterol maleate / mometasone furoate | DRUG | Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device. |
| placebo to indacaterol maleate/mometasone furoate | DRUG | Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. |
| formoterol | DRUG | Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. |
| placebo to formoterol | DRUG | Placebo AEROLIZER® device |
| short acting β2-agonist | DRUG | 100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI). |
| indacaterol maleate/mometasone furoate | DRUG | Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device. |
| fluticasone proprionate / salmeterol xinafoate | DRUG | Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device. |
Inclusion Criteria: * Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening) * Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 mont...