A Phase 3 interventional study of Indacaterol 150 µg and Tiotropium in Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals. Completed at 423 sites in 40 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 3,439 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol 150 µg
Tiotropium 18 µg o.d. delivered via the handihaler®
Drug: Tiotropium
Indacaterol 150 µg o.d. delivered via SDDPI
Tiotropium 18 µg o.d. delivered via handihaler®
Trough Forced Expiratory Volume in 1 Second (FEV1).
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
Time frame: 12 weeks
Rate of COPD Exacerbations
COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.
Time frame: 52 weeks
3,444 patients were randomized, but only 3,439 received treatment as 5 patients were mis-randomized.
| Milestone | Indacaterol | Tiotropium |
|---|---|---|
| Started | 1723 | 1721 |
| Exposed | 1721 | 1718 |
| Completed | 1337 | 1379 |
| Not completed | 386 | 342 |
| Withdrew: Abnormal laboratory value (s) | 2 | 2 |
| Withdrew: Patient's inability to use the device | 4 | 6 |
| Withdrew: Abnormal test procedure result (s) | 7 | 2 |
| Withdrew: Lost to follow-up | 22 | 13 |
| Withdrew: Death | 24 | 26 |
| Withdrew: Administrative problems | 34 | 26 |
| Withdrew: Protocol violation | 36 | 24 |
| Withdrew: Lack of efficacy | 51 | 39 |
| Withdrew: Adverse event | 101 | 96 |
| Withdrew: Withdrawal by subject | 105 | 108 |
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
| Liters | Indacaterol | Tiotropium |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1). | 1.134 ± 0.0008 | 1.145 ± 0.0008 |
COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.
| Exacerbations per patient per year | Indacaterol | Tiotropium |
|---|---|---|
| Rate of COPD Exacerbations | 0.79 | 0.61 |
Non-serious events are listed at a 1.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IndIndacaterol | — | 263/1,721 (15.3%) | 890/1,721 (51.7%) |
| Tiotropium | — | 255/1,718 (14.8%) | 793/1,718 (46.2%) |
| Event | IndIndacaterol | Tiotropium |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 147/1721 | 121/1718 |
| PneumoniaInfections and infestations | 29/1721 | 24/1718 |
| Lower respiratory tract infectionInfections and infestations | 28/1721 | 18/1718 |
| Upper respiratory tract infection bacterialInfections and infestations | 18/1721 | 16/1718 |
| Viral upper respiratory tract infectionInfections and infestations | 12/1721 | 11/1718 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 12/1721 | 4/1718 |
| Myocardial infarctionCardiac disorders | 4/1721 | 8/1718 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/1721 | 6/1718 |
| Myocardial ischaemiaCardiac disorders | 6/1721 | 4/1718 |
| Angina pectorisCardiac disorders | 5/1721 | 5/1718 |
| Event | IndIndacaterol | Tiotropium |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 668/1721 | 591/1718 |
| Upper respiratory tract infection bacterialInfections and infestations | 139/1721 | 127/1718 |
| Lower respiratory tract infectionInfections and infestations | 125/1721 | 98/1718 |
| NasopharyngitisInfections and infestations | 118/1721 | 101/1718 |
| CoughRespiratory, thoracic and mediastinal disorders | 107/1721 | 56/1718 |
| Viral upper respiratory tract infectionInfections and infestations | 91/1721 | 65/1718 |
| Upper respiratory tract infectionInfections and infestations | 70/1721 | 63/1718 |
| HypertensionVascular disorders | 63/1721 | 48/1718 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 56/1721 | 50/1718 |
| HeadacheNervous system disorders | 53/1721 | 49/1718 |
| Age, Customized(Participants) | Indacaterol | Tiotropium | Total |
|---|---|---|---|
| <65 years | 929 | 909 | 1838 |
| ≥ 65 years | 792 | 809 | 1601 |
| Sex: Female, Male(Participants) | Indacaterol | Tiotropium | Total |
|---|---|---|---|
| Female | 377 | 405 | 782 |
| Male | 1344 | 1313 | 2657 |
Showing the first 100 of 423 sites across 40 countries.
The record gives a start of Mar 2009, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 1 year 4 months after primary completion.
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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indacaterol
Pulmonary Disease, Chronic Obstructive →