| November 23, 2006 |
| July 22, 2011 |
| November 2006 |
| November 2007 (Final data collection date for primary outcome measure) |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: 22, 23, and 24 hours post-dose on Day 2 ] 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. |
| Lung function measured from 22-24 hours after having taken medication, by a special test "forced expiratory volume in 1 second" (FEV1). |
| Complete list of historical versions of study NCT00403754 on ClinicalTrials.gov Archive Site |
- Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: 5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2 ]
Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.
- Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 [ Time Frame: 5 minutes to 4 hours post-dose on Day 1 ]
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. 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.
- Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2 [ Time Frame: 5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2 ]
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 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.
|
| FEV1 at 5, 15 and 30 min, 1, 2, 4, 8, and 12 hours post-dose;standardized FEV1 area under the curve (AUC) between 0-24hours post dose;peak FEV1 |
| Not Provided |
| Not Provided |
| |
| Dose Ranging Study for Indacaterol in Japanese Asthma Patients |
| A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Single-dose, Dose-ranging Study Followed by a Single Day's Treatment With Open Label Salmeterol Bid (100 µg/Day), to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, & 600 µg) Delivered Via Single Dose Dry Powder Inhaler (SDDPI) in Japanese Asthma Patients |
| This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Asthma |
- Drug: Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
Other Name: QAB149
- Drug: Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
- Drug: Salmeterol
Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Other Name: Serevent
|
- Experimental: Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol
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. Interventions:
- Drug: Indacaterol
- Drug: Placebo
- Drug: Salmeterol
- Experimental: Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol
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. Interventions:
- Drug: Indacaterol
- Drug: Placebo
- Drug: Salmeterol
- Experimental: Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol
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. Interventions:
- Drug: Indacaterol
- Drug: Placebo
- Drug: Salmeterol
- Experimental: Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol
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. Interventions:
- Drug: Indacaterol
- Drug: Placebo
- Drug: Salmeterol
|
| Not Provided |
| |
| Completed |
| 41 |
| November 2007 |
| November 2007 (Final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male and female Japanese asthmatic patients aged 18 to 75 years old.
Exclusion Criteria:
- Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
- Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
- Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women.
- Patients who have had treatment with disallowed medications including investigational drug.
Other protocol-defined inclusion/exclusion criteria applied to the study. |
| Sexes Eligible for Study: |
All |
|
| 18 Years to 75 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| |
| NCT00403754 |
| CQAB149A1202 |
| No |
| Not Provided |
| Not Provided |
| External Affairs, Novartis |
| Novartis Pharmaceuticals |
| Not Provided |
| Principal Investigator: |
Novartis Pharmaceuticals Japan |
Novartis Pharmaceuticals Japan |
|
| Novartis |
| July 2011 |
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