A Phase 3 interventional study of Indacaterol and Salmeterol in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 71 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-19.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 511 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of asthma, and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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.
Drug: Indacaterol · Drug: Placebo to Salmeterol
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.
Drug: Indacaterol · Drug: Placebo to Salmeterol
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.
Drug: Indacaterol · Drug: Placebo to Salmeterol
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.
Drug: Indacaterol · Drug: Placebo to Salmeterol
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.
Drug: Salmeterol · Drug: Placebo to Indacaterol
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.
Drug: Placebo to Indacaterol · Drug: Placebo to Salmeterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
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.
Time frame: Day 15 (after 2 weeks of treatment)
Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
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 on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Time frame: Day 2 (after 1 day of treatment)
| Milestone | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo |
|---|---|---|---|---|---|---|
| Started | 85 | 85 | 84 | 86 | 86 | 85 |
| Safety set: received study drug | 84 | 81 | 84 | 85 | 84 | 84 |
| Full analysis set (fas) | 84 | 80 | 83 | 85 | 84 | 84 |
| Completed | 83 | 78 | 83 | 81 | 78 | 80 |
| Not completed | 2 | 7 | 1 | 5 | 8 | 5 |
| Withdrew: Adverse event | 1 | 1 | 0 | 1 | 5 | 1 |
| Withdrew: Administrative problems | 1 | 3 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 | 3 |
| Withdrew: Protocol deviation | 0 | 2 | 1 | 2 | 0 | 0 |
| Withdrew: Abnormal test procedure result(s) | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Unsatisfactory therapeutic effect | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
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.
| Liters | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo |
|---|---|---|---|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment | 2.50 ± 0.036 | 2.52 ± 0.037 | 2.59 ± 0.036 | 2.54 ± 0.037 | 2.54 ± 0.037 | 2.42 ± 0.036 |
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 on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
| Liters | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo |
|---|---|---|---|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment | 2.46 ± 0.026 | 2.52 ± 0.027 | 2.54 ± 0.026 | 2.60 ± 0.026 | 2.65 ± 0.027 | 2.45 ± 0.027 |
Collected over 2 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol 18.75 µg | — | 0/84 (0%) | 4/84 (4.8%) |
| Indacaterol 37.5 µg | — | 0/81 (0%) | 2/81 (2.5%) |
| Indacaterol 75 µg | — | 0/84 (0%) | 12/84 (14.3%) |
| Indacaterol 150 µg | — | 1/85 (1.2%) | 7/85 (8.2%) |
| Salmeterol | — | 0/84 (0%) | 5/84 (6%) |
| Placebo | — | 0/84 (0%) | 4/84 (4.8%) |
| Event | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo |
|---|---|---|---|---|---|---|
| Substance abusePsychiatric disorders | 0/84 | 0/81 | 0/84 | 1/85 | 0/84 | 0/84 |
| Event | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo |
|---|---|---|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 2/84 | 0/81 | 8/84 | 4/85 | 1/84 | 0/84 |
| HeadacheNervous system disorders | 2/84 | 2/81 | 5/84 | 3/85 | 4/84 | 4/84 |
| Age Continuous(years) | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 42.0 ± 14.64 | 41.9 ± 14.96 | 40.2 ± 14.71 | 41.0 ± 15.20 | 40.9 ± 14.56 | 40.6 ± 14.17 | 41.1 ± 14.65 |
| Sex: Female, Male(Participants) | Indacaterol 18.75 µg | Indacaterol 37.5 µg | Indacaterol 75 µg | Indacaterol 150 µg | Salmeterol | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 42 | 46 | 49 | 55 | 46 | 40 | 278 |
| Male | 42 | 35 | 35 | 30 | 38 | 44 | 224 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals