Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Sequence A, Part 2: Sequence A | Experimental | 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. |
|
| Part 1 : Sequence B, Part 2: Sequence B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.
| 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. | 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. | 24 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1.5 hour post dose to max heart rate during exercise |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Antwerp | Belgium |
The study was double blind with regard to the administration of indacaterol and placebo and open label with regard to salmeterol. The study had 2 parts. Each Part of the study consisted of 3 treatment periods separated by a minimum of 7 days. The two parts of the study were separated by a minimum of 7 days.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Sequence A, Part 2: Sequence A | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 1: Sequence C, Part 2: Sequence C | Experimental | 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. |
|
| Part 1; Sequence D, Part 2: Sequence D | Experimental | 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. |
|
| Part 1: Sequence E, Part 2: Sequence E | Experimental | 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. |
|
| Part 1: Sequence F, Part 2: Sequence F | Experimental | 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. |
|
| Placebo | Drug | Single dose indacaterol matching placebo via Concept 1 device |
|
| Salmeterol | Drug | 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. |
|
| 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. | 23 hours 30 minutes and 24 hours post-dose at Day 1 |
| FG001 | Part 1 : Sequence B, Part 2: Sequence B | 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. |
| FG002 | Part 1: Sequence C, Part 2: Sequence C | 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. |
| FG003 | Part 1; Sequence D, Part 2: Sequence D | 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. |
| FG004 | Part 1: Sequence E, Part 2: Sequence E | 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. |
| FG005 | Part 1: Sequence F, Part 2: Sequence F | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 1: Period 2 |
|
| Part 1: Period 3 |
|
|
| Part 2: Period 1 |
|
|
| Part 2: Period 2 |
|
| Part 2: Period 3 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Sequence A, Part 2: Sequence A | 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. |
| BG001 | Part 1 : Sequence B, Part 2: Sequence B | 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. |
| BG002 | Part 1: Sequence C, Part 2: Sequence C | 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. |
| BG003 | Part 1; Sequence D, Part 2: Sequence D | 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. |
| BG004 | Part 1: Sequence E, Part 2: Sequence E | 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. |
| BG005 | Part 1: Sequence F, Part 2: Sequence F | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety population consisted of all subjects who received at least one dose of study medication after randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24-hours post-dose on Day 1 (of each treatment) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | The safety population consisted of all subjects who received at least one dose of study medication after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Beats per minute (bpm) | 1.5 hour post dose to max heart rate during exercise |
| ||||||||||||||||||||||||||||||
| Primary | 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.
| Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 hours post dose on Day 1 |
| ||||||||||||||||||||||||||||||
| Primary | 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. | The safety population consisted of all subjects who received at least one dose of study medication after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Beats per minute (bpm) | 2 hour post-dose on Day 1 |
| ||||||||||||||||||||||||||||||
| Primary | 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. | The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. | Posted | Least Squares Mean | 95% Confidence Interval | Beats per minute (bpm) | 24 hours post dose on Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The safety population consisted of all subjects who received at least one dose of study medication after randomization. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 23 hours 30 minutes and 24 hours post-dose at Day 1 |
|
Not provided
All patients who received at least one dose of treatment were included in the safety and tolerability evaluation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1:Indacaterol 300mcg | Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). | 1 | 26 | 9 | 26 | ||
| EG001 | Part 1:Salmeterol 50mcg | Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). | 0 | 25 | 4 | 25 | ||
| EG002 | Part 1:Placebo | Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). | 1 | 26 | 4 | 26 | ||
| EG003 | Part 2:Indacaterol 300μg Morning/Placebo Evening | 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. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. | 0 | 23 | 8 | 23 | ||
| EG004 | Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg | Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. | 0 | 24 | 8 | 24 | ||
| EG005 | Part 2:Placebo Morning/Placebo Evening | Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. | 0 | 23 | 6 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA 10.X | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.X | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 10.X | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Catheter thrombosis | General disorders | MedDRA 10.X | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.X | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.X | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 10.X | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.X | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.X | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 10.X | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 10.X | Systematic Assessment |
| |
| Diastolic hypertension | Vascular disorders | MedDRA 10.X | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
|
|
| Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening |
Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
|
|
|
|
| OG001 |
| Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening |
Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
| OG002 | Part 2:Placebo Morning/Placebo Evening | Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
|
|
| OG003 | Part 2:Indacaterol 300μg Morning/Placebo Evening | 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. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
| OG004 | Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening | Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
| OG005 | Part 2:Placebo Morning/Placebo Evening | Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. |
|
|