A Phase 2 interventional study of Indacaterol and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Novartis. Completed at 1 site in Belgium. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-23.
Sponsored by Novartis · Phase 2, Interventional, and Treatment
This study investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Drug: Indacaterol · Drug: Placebo · Drug: Salmeterol
Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).
Single dose indacaterol matching placebo via Concept 1 device
Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.
Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study
The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.
Time frame: 24-hours post-dose on Day 1 (of each treatment)
Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study
The percentage of patients with an increase of \>= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined. * 0-12 hours: post first dose measurements up to second dose * 12-24 hours: post second dose measurement up to and including the 24 hour measurement * 0-24 hours: all post dose measurements up to and including the 24 hour measurement
Time frame: 24 hours post dose on Day 1
Maximum Heart Rate During Exercise in Part 1
Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.
Time frame: 2 hour post-dose on Day 1
Maximum Heart Rate (HR) During Salbutamol Administration in Part 2
Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.
Time frame: 24 hours post dose on Day 1
Change in Heart Rate During Exercise in Part 1
Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise. Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate.
Time frame: 1.5 hour post dose to max heart rate during exercise
Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.
Time frame: 23 hours 30 minutes and 24 hours post-dose at Day 1
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 4 | 5 | 4 | 5 | 4 | 5 |
| Completed | 4 | 4 | 4 | 4 | 4 | 5 |
| Not completed | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 0 | 0 | 1 | 0 | 0 |
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 5 |
| Completed | 4 | 4 | 4 | 4 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 4 | 5 |
| Completed | 3 | 4 | 4 | 4 | 4 | 5 |
| Not completed | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 3 | 4 | 4 | 4 | 4 | 5 |
| Completed | 3 | 4 | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 3 | 4 | 4 | 4 | 4 | 4 |
| Completed | 3 | 4 | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F |
|---|---|---|---|---|---|---|
| Started | 3 | 4 | 4 | 4 | 4 | 4 |
| Completed | 2 | 4 | 4 | 4 | 4 | 3 |
| Not completed | 1 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Abnormal test procedure | 1 | 0 | 0 | 0 | 0 | 1 |
The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.
| Percentage of participants | Part 1: Indacaterol 300μg | Part 1 : Salmeterol 50μg |
|---|---|---|
| Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study | 20.00 (6.83 to 40.70) | 16.0 (4.54 to 36.0) |
Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise. Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate.
| Beats per minute (bpm) | Part 1: Indacaterol 300μg | Part 1 : Salmeterol 50μg | Part 1: Placebo |
|---|---|---|---|
| Change in Heart Rate During Exercise in Part 1 | 66.246 (58.941 to 73.551) | 64.265 (56.868 to 71.663) | 63.058 (55.761 to 70.355) |
The percentage of patients with an increase of \>= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined. * 0-12 hours: post first dose measurements up to second dose * 12-24 hours: post second dose measurement up to and including the 24 hour measurement * 0-24 hours: all post dose measurements up to and including the 24 hour measurement
| Percentage of participants | Part 2:Indacaterol 300μg Morning/Placebo Evening | Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening |
|---|---|---|
| 0 - 12 hours (N= 23,23) | 17.39 (4.95 to 38.78) | 17.39 (4.95 to 38.78) |
| 12 - 24 hours (N= 20, 20) | 10.00 (1.23 to 31.70) | 25.00 (8.66 to 49.10) |
| 0 - 24 hours (N= 23, 23) | 13.04 (2.78 to 33.59) | 17.39 (4.95 to 38.78) |
Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.
| Beats per minute (bpm) | Part 1: Indacaterol 300μg | Part 1 : Salmeterol 50μg | Part 1: Placebo |
|---|---|---|---|
| Maximum Heart Rate During Exercise in Part 1 | 133.13 (125.90 to 140.36) | 131.18 (123.86 to 138.49) | 129.96 (122.73 to 137.19) |
Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.
| Beats per minute (bpm) | Part 2:Indacaterol 300μg Morning/Placebo Evening | Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening | Part 2:Placebo Morning/Placebo Evening |
|---|---|---|---|
| 0 - 12 hours (N= 23, 24, 23) | 98.026 (90.407 to 105.645) | 98.087 (90.575 to 105.598) | 97.960 (90.317 to 105.603) |
| 12 - 24 hours (N= 20, 21, 20) | 97.179 (91.195 to 103.164) | 99.954 (94.047 to 105.861) | 97.786 (91.779 to 103.794) |
| 0 - 24 hours (N= 23, 24, 23) | 102.501 (95.504 to 109.498) | 102.303 (95.394 to 109.212) | 103.951 (96.931 to 110.971) |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.
| Liters | Part 1: Indacaterol 300μg | Part 1 : Salmeterol 50μg | Part 1: Placebo | Part 2:Indacaterol 300μg Morning/Placebo Evening | Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening | Part 2:Placebo Morning/Placebo Evening |
|---|---|---|---|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2 | 1.72 (1.65 to 1.79) | 1.59 (1.52 to 1.66) | 1.56 (1.49 to 1.63) | 1.75 (1.67 to 1.82) | 1.68 (1.60 to 1.75) | 1.54 (1.46 to 1.62) |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1:Indacaterol 300mcg | — | 1/26 (3.8%) | 9/26 (34.6%) |
| Part 1:Salmeterol 50mcg | — | 0/25 (0%) | 4/25 (16%) |
| Part 1:Placebo | — | 1/26 (3.8%) | 4/26 (15.4%) |
| Part 2:Indacaterol 300μg Morning/Placebo Evening | — | 0/23 (0%) | 8/23 (34.8%) |
| Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg | — | 0/24 (0%) | 8/24 (33.3%) |
| Part 2:Placebo Morning/Placebo Evening | — | 0/23 (0%) | 6/23 (26.1%) |
| Event | Part 1:Indacaterol 300mcg | Part 1:Salmeterol 50mcg | Part 1:Placebo | Part 2:Indacaterol 300μg Morning/Placebo Evening | Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg | Part 2:Placebo Morning/Placebo Evening |
|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/26 | 0/25 | 1/26 | 0/23 | 0/24 | 0/23 |
| TonsillectomySurgical and medical procedures | 1/26 | 0/25 | 0/26 | 0/23 | 0/24 | 0/23 |
| Event | Part 1:Indacaterol 300mcg | Part 1:Salmeterol 50mcg | Part 1:Placebo | Part 2:Indacaterol 300μg Morning/Placebo Evening | Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg | Part 2:Placebo Morning/Placebo Evening |
|---|---|---|---|---|---|---|
| TremorNervous system disorders | 0/26 | 0/25 | 0/26 | 2/23 | 3/24 | 2/23 |
| DizzinessNervous system disorders | 1/26 | 0/25 | 0/26 | 0/23 | 1/24 | 2/23 |
| HeadacheNervous system disorders | 0/26 | 1/25 | 1/26 | 0/23 | 2/24 | 1/23 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/26 | 0/25 | 1/26 | 1/23 | 0/24 | 0/23 |
| Abdominal painGastrointestinal disorders | 0/26 | 0/25 | 0/26 | 1/23 | 0/24 | 0/23 |
| DiarrhoeaGastrointestinal disorders | 1/26 | 0/25 | 0/26 | 1/23 | 1/24 | 0/23 |
| ChillsGeneral disorders | 0/26 | 0/25 | 0/26 | 1/23 | 0/24 | 0/23 |
| FatigueGeneral disorders | 0/26 | 0/25 | 0/26 | 0/23 | 0/24 | 1/23 |
| NasopharyngitisInfections and infestations | 1/26 | 0/25 | 0/26 | 1/23 | 0/24 | 1/23 |
| Neck painMusculoskeletal and connective tissue disorders | 0/26 | 0/25 | 0/26 | 0/23 | 0/24 | 1/23 |
| Age Continuous(years) | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Mean | 59.0 ± 9.20 | 63.0 ± 7.58 | 58.5 ± 5.07 | 58.4 ± 5.18 | 60.5 ± 5.80 | 61.6 ± 5.86 | 60.3 ± 6.17 |
| Sex: Female, Male(Participants) | Part 1: Sequence A, Part 2: Sequence A | Part 1 : Sequence B, Part 2: Sequence B | Part 1: Sequence C, Part 2: Sequence C | Part 1; Sequence D, Part 2: Sequence D | Part 1: Sequence E, Part 2: Sequence E | Part 1: Sequence F, Part 2: Sequence F | Total |
|---|---|---|---|---|---|---|---|
| Female | 2 | 2 | 1 | 1 | 1 | 0 | 7 |
| Male | 2 | 3 | 3 | 4 | 3 | 5 | 20 |
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