Trial record 1 of 3 for:    b2354
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12-week Efficacy of Indacaterol

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01072448
First received: February 19, 2010
Last updated: July 22, 2011
Last verified: July 2011
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 75 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 75 μg Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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.
Placebo to Indacaterol Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 75 μg     Placebo to Indacaterol  
STARTED     163     160  
COMPLETED     144     130  
NOT COMPLETED     19     30  
Adverse Event                 9                 10  
Subject withdrew consent                 4                 9  
Protocol deviation                 3                 4  
Abnormal test procedure result(s)                 1                 0  
Unsatisfactory therapeutic effect                 1                 3  
Lost to Follow-up                 1                 1  
Abnormal laboratory value(s)                 0                 1  
Death                 0                 2  



  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.
No text entered.

Reporting Groups
  Description
Indacaterol 75 μg Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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.
Placebo to Indacaterol Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 75 μg     Placebo to Indacaterol     Total  
Number of Participants  
[units: participants]
  163     160     323  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.29     64.1  ± 9.43     64.0  ± 8.86  
Gender  
[units: participants]
     
Female     74     73     147  
Male     89     87     176  



  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)   [ Time Frame: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85) ]

2.  Secondary:   Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)   [ Time Frame: End of the study (Week 12, Day 84) ]


  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: NCT01072448     History of Changes
Other Study ID Numbers: CQAB149B2354
Study First Received: February 19, 2010
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration