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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00846586
First received: February 15, 2009
Last updated: July 22, 2011
Last verified: July 2011
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Indacaterol 150 μg
Drug: Tiotropium 18 μg
Drug: Placebo to indacaterol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Indacaterol 150 μg and Tiotropium 18 μg Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Tiotropium 18 μg Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Participant Flow:   Overall Study
    Indacaterol 150 μg and Tiotropium 18 μg     Tiotropium 18 μg  
STARTED     570     564  
Received Study Drug     570     561 [1]
COMPLETED     531     529  
NOT COMPLETED     39     35  
Adverse Event                 20                 10  
Subject withdrew consent                 8                 10  
Administrative problems                 5                 4  
Death                 2                 0  
Protocol deviation                 2                 6  
Abnormal test procedure result(s)                 1                 0  
Lost to Follow-up                 1                 4  
Unsatisfactory therapeutic effect                 0                 1  
[1] Three patients were not exposed to study treatment in this group.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Indacaterol 150 μg and Tiotropium 18 μg Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Tiotropium 18 μg Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Total Total of all reporting groups

Baseline Measures
    Indacaterol 150 μg and Tiotropium 18 μg     Tiotropium 18 μg     Total  
Number of Participants  
[units: participants]
  570     561     1131  
Age [1]
[units: years]
Mean ± Standard Deviation
  64.0  ± 9.07     63.4  ± 9.22     63.7  ± 9.14  
Gender  
[units: participants]
     
Female     171     183     354  
Male     399     378     777  
[1] Demographics are reported for the safety set which includes all patients who received at least 1 dose of study drug.



  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)   [ Time Frame: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84) ]

2.  Secondary:   Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)   [ Time Frame: 24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85) ]

3.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1   [ Time Frame: From 5 minutes to 8 hours post-dose on Day 1 ]

4.  Secondary:   Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2   [ Time Frame: 24 hours post-dose on Day 2 ]

5.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1   [ Time Frame: From 5 minutes to 4 hours post-dose on Day 1 ]

6.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)   [ Time Frame: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00846586     History of Changes
Other Study ID Numbers: CQAB149B2341
Study First Received: February 15, 2009
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
South Africa: Medicines Control Council
Philippines: Bureau of Food and Drugs
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Guatemala: Comisión para la Evaluación de Ensayos Clínicos Ministerio de Salud Pública y Asistencia Social
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica