Niyati Prasad - Academia.edu (original) (raw)

Papers by Niyati Prasad

Research paper thumbnail of Randomized Double-Blind Controlled Trial of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

American Journal of Respiratory and Critical Care Medicine, Sep 1, 2017

and Johnson, and Vifor Pharma, payment for lectures including service on speakers bureaus from Bo... more and Johnson, and Vifor Pharma, payment for lectures including service on speakers bureaus from Boehringer Ingelheim, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Almirall, and Chiesi, outside the submitted work. Gavin Donaldson reports personal fees from MiCom SRL, Milan, Italy, outside the submitted work. Richa Singh reports personal lecture fees from Chiesi, outside the submitted work. Tsz Keung Nip is an employee of Takeda Pharmaceuticals. Udo-Michael Goehring and Niyati Prasad were employees of Takeda Pharmaceuticals at the time of the study. Anant Patel and Raymond Sapsford have nothing to disclose. FUNDING All funding for this study was provided by Takeda Pharmaceuticals. AUTHOR CONTRIBUTIONS AJM, GCD, UMG and JAW conceived the idea for the study; data collection and laboratory analysis was undertaken by AJM, ARCP, RS, RJS and data analysis by TKN; all authors contributed to data interpretation and the writing of the paper.

Research paper thumbnail of Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis

JAMA

ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary... more ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).ObjectiveTo assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF.Design, Setting, and ParticipantsThe 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2.InterventionsPatients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 w...

Research paper thumbnail of A 24‐Week , Phase IIa , Randomized, Double‐Blind , Placebo‐Controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis

Arthritis & Rheumatology

Research paper thumbnail of Efficacy and Safety of Indacaterol 150 µg Once-Daily in COPD: A 12-Week Study

C48. COPD: PHARMACOLOGICAL TREATMENT BETA AGONIST, 2009

Research paper thumbnail of Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day

Journal of asthma and allergy, 2017

The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of pa... more The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 µg/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use. In a double-blind, randomized, parallel-group study, 367 patients were allocated to one of three treatment arms (Cic 160, 320 and 640 µg/day). After a single-blind, 3-week baseline period with Cic 160 µg/day, eligible patients were randomized to receive 52 weeks of treatment with Cic 160, 320 or 640 µg/day (double-blind period) during which forced expiratory volume in 1 second (FEV1), exacerbations and Asthma Control Questionnaire (ACQ) scores were measured. Treatment with all the three doses was associated with significant improvements in ACQ scores, FEV1 and asthma symptoms ...

Research paper thumbnail of Efficacy And Safety Of Indacaterol 150 And 300g In Asian COPD Patients: A 12-Week, Placebo Controlled Study

A45. BRONCHODILATORS FOR COPD: OLD FAITHFULS AND NOVEL COMPOUNDS, 2011

Research paper thumbnail of Chronic obstructive pulmonary disease in China: the potential role of indacaterol

Journal of thoracic disease, 2013

Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortali... more Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortality in China, with tobacco smoking, biomass fuel use and genetic susceptibility being the major risk factors. COPD poses a high economic burden with the total expenditure per patient costing 40% and nearly one-third of an average family income in urban and rural areas of China, respectively. Despite the use of the Global Initiative for Chronic Obstructive Lung Disease strategy document being recommended for the diagnosis and management of COPD, the majority of patients with COPD go undiagnosed or are not managed appropriately by physicians. Long-acting β2-agonists (LABAs) have long been used for symptomatic management of COPD, with salmeterol and formoterol being the commonly used twice-daily treatments. Indacaterol is the first once-daily LABA, approved at a dose of 150 µg once daily in China. Several phase III studies have shown that indacaterol 150 µg improves lung function, breathless...

Research paper thumbnail of Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population

Respiratory medicine, 2012

This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-act... more This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior ...

Research paper thumbnail of Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: A 12-week, placebo-controlled study

Respirology, 2012

The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonis... more The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan. Moderate-to-severe COPD patients were randomized to indacaterol 150 µg, indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated. A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV(1) % predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV(1) at week 12 for indacaterol 150 µg, indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: -4.8 and -5.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported. Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.

Research paper thumbnail of Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients

Respiratory Medicine, 2010

NVA237 once-daily was effective and well tolerated versus placebo, and demonstrated rapid and sus... more NVA237 once-daily was effective and well tolerated versus placebo, and demonstrated rapid and sustained 24-h bronchodilation. (ClinicalTrials.gov Identifier: NCT00501852).

Research paper thumbnail of Efficacy and safety of indacaterol 150 μg once-daily in COPD: a double-blind, randomised, 12-week study

BMC Pulmonary Medicine, 2010

BackgroundIndacaterol is a novel, once-daily (o.d.) inhaled, long-actingβ2-agonist in development... more BackgroundIndacaterol is a novel, once-daily (o.d.) inhaled, long-actingβ2-agonist in development for chronic obstructive pulmonary disease (COPD). This 12-week, double-blind study compared the efficacy, safety, and tolerability of indacaterol to that of placebo in patients with moderate-to-severe COPD.MethodsEfficacy variables included 24-h trough FEV1(mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (primary endpoint) and after Day 1, and the percentage of COPD days with poor control (i.e., worsening symptoms). Safety was assessed by adverse events (AEs), mean serum potassium and blood glucose, QTc (Fridericia), and vital signs.ResultsPatients were randomised (n = 416, mean age 63 years) to receive either indacaterol 150μg o.d. (n = 211) or placebo (n = 205) via a single-dose dry-powder inhaler; 87.5% completed the study. Trough FEV1(LSM ± SEM) at Week 12 was 1.48 ± 0.018 L for indacaterol and 1.35 ± 0.019 L for placebo, a clinically relevant difference of 130 ± 24 mL (p ...

Research paper thumbnail of Randomized Double-Blind Controlled Trial of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

American Journal of Respiratory and Critical Care Medicine, Sep 1, 2017

and Johnson, and Vifor Pharma, payment for lectures including service on speakers bureaus from Bo... more and Johnson, and Vifor Pharma, payment for lectures including service on speakers bureaus from Boehringer Ingelheim, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Almirall, and Chiesi, outside the submitted work. Gavin Donaldson reports personal fees from MiCom SRL, Milan, Italy, outside the submitted work. Richa Singh reports personal lecture fees from Chiesi, outside the submitted work. Tsz Keung Nip is an employee of Takeda Pharmaceuticals. Udo-Michael Goehring and Niyati Prasad were employees of Takeda Pharmaceuticals at the time of the study. Anant Patel and Raymond Sapsford have nothing to disclose. FUNDING All funding for this study was provided by Takeda Pharmaceuticals. AUTHOR CONTRIBUTIONS AJM, GCD, UMG and JAW conceived the idea for the study; data collection and laboratory analysis was undertaken by AJM, ARCP, RS, RJS and data analysis by TKN; all authors contributed to data interpretation and the writing of the paper.

Research paper thumbnail of Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis

JAMA

ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary... more ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).ObjectiveTo assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF.Design, Setting, and ParticipantsThe 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2.InterventionsPatients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 w...

Research paper thumbnail of A 24‐Week , Phase IIa , Randomized, Double‐Blind , Placebo‐Controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis

Arthritis & Rheumatology

Research paper thumbnail of Efficacy and Safety of Indacaterol 150 µg Once-Daily in COPD: A 12-Week Study

C48. COPD: PHARMACOLOGICAL TREATMENT BETA AGONIST, 2009

Research paper thumbnail of Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day

Journal of asthma and allergy, 2017

The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of pa... more The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 µg/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use. In a double-blind, randomized, parallel-group study, 367 patients were allocated to one of three treatment arms (Cic 160, 320 and 640 µg/day). After a single-blind, 3-week baseline period with Cic 160 µg/day, eligible patients were randomized to receive 52 weeks of treatment with Cic 160, 320 or 640 µg/day (double-blind period) during which forced expiratory volume in 1 second (FEV1), exacerbations and Asthma Control Questionnaire (ACQ) scores were measured. Treatment with all the three doses was associated with significant improvements in ACQ scores, FEV1 and asthma symptoms ...

Research paper thumbnail of Efficacy And Safety Of Indacaterol 150 And 300g In Asian COPD Patients: A 12-Week, Placebo Controlled Study

A45. BRONCHODILATORS FOR COPD: OLD FAITHFULS AND NOVEL COMPOUNDS, 2011

Research paper thumbnail of Chronic obstructive pulmonary disease in China: the potential role of indacaterol

Journal of thoracic disease, 2013

Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortali... more Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortality in China, with tobacco smoking, biomass fuel use and genetic susceptibility being the major risk factors. COPD poses a high economic burden with the total expenditure per patient costing 40% and nearly one-third of an average family income in urban and rural areas of China, respectively. Despite the use of the Global Initiative for Chronic Obstructive Lung Disease strategy document being recommended for the diagnosis and management of COPD, the majority of patients with COPD go undiagnosed or are not managed appropriately by physicians. Long-acting β2-agonists (LABAs) have long been used for symptomatic management of COPD, with salmeterol and formoterol being the commonly used twice-daily treatments. Indacaterol is the first once-daily LABA, approved at a dose of 150 µg once daily in China. Several phase III studies have shown that indacaterol 150 µg improves lung function, breathless...

Research paper thumbnail of Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population

Respiratory medicine, 2012

This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-act... more This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior ...

Research paper thumbnail of Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: A 12-week, placebo-controlled study

Respirology, 2012

The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonis... more The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan. Moderate-to-severe COPD patients were randomized to indacaterol 150 µg, indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated. A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV(1) % predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV(1) at week 12 for indacaterol 150 µg, indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: -4.8 and -5.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported. Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.

Research paper thumbnail of Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients

Respiratory Medicine, 2010

NVA237 once-daily was effective and well tolerated versus placebo, and demonstrated rapid and sus... more NVA237 once-daily was effective and well tolerated versus placebo, and demonstrated rapid and sustained 24-h bronchodilation. (ClinicalTrials.gov Identifier: NCT00501852).

Research paper thumbnail of Efficacy and safety of indacaterol 150 μg once-daily in COPD: a double-blind, randomised, 12-week study

BMC Pulmonary Medicine, 2010

BackgroundIndacaterol is a novel, once-daily (o.d.) inhaled, long-actingβ2-agonist in development... more BackgroundIndacaterol is a novel, once-daily (o.d.) inhaled, long-actingβ2-agonist in development for chronic obstructive pulmonary disease (COPD). This 12-week, double-blind study compared the efficacy, safety, and tolerability of indacaterol to that of placebo in patients with moderate-to-severe COPD.MethodsEfficacy variables included 24-h trough FEV1(mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (primary endpoint) and after Day 1, and the percentage of COPD days with poor control (i.e., worsening symptoms). Safety was assessed by adverse events (AEs), mean serum potassium and blood glucose, QTc (Fridericia), and vital signs.ResultsPatients were randomised (n = 416, mean age 63 years) to receive either indacaterol 150μg o.d. (n = 211) or placebo (n = 205) via a single-dose dry-powder inhaler; 87.5% completed the study. Trough FEV1(LSM ± SEM) at Week 12 was 1.48 ± 0.018 L for indacaterol and 1.35 ± 0.019 L for placebo, a clinically relevant difference of 130 ± 24 mL (p ...