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Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.) (INSTEAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01555138
First received: March 13, 2012
Last updated: April 8, 2015
Last verified: April 2015
Results First Received: February 10, 2015  
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
Drug: Salmeterol

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Indacaterol Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Salmeterol/Fluticasone Propionate Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)

Participant Flow:   Overall Study
    Indacaterol   Salmeterol/Fluticasone Propionate
STARTED   293   288 
COMPLETED   246   250 
NOT COMPLETED   47   38 
Death                0                1 
Lost to Follow-up                1                0 
Abnormal Lab reults                1                3 
Lack of Efficacy                2                2 
Protocol Violation                5                3 
Administrative problems                8                0 
Withdrawal by Subject                16                15 
Adverse Event                14                14 



  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 Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Salmeterol/Fluticasone Propionate Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
Total Total of all reporting groups

Baseline Measures
   Indacaterol   Salmeterol/Fluticasone Propionate   Total 
Overall Participants Analyzed 
[Units: Participants]
 293   288   581 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (8.39)   66.8  (8.53)   66.0  (8.49) 
Gender 
[Units: Participants]
     
Female   89   91   180 
Male   204   197   401 


  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons   [ Time Frame: 12 weeks ]

2.  Secondary:   Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons   [ Time Frame: 26 weeks ]

3.  Secondary:   FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons   [ Time Frame: 12 weeks ]

4.  Secondary:   FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons   [ Time Frame: 26 weeks ]

5.  Secondary:   FVC Over 26 Weeks of Treatment   [ Time Frame: 12 and 26 weeks ]

6.  Secondary:   Analysis of AUC (5 Min – 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison   [ Time Frame: 12 and 26 weeks ]

7.  Secondary:   TDI Focal Score at Week 12 and Week 26: Treatment Comparisons   [ Time Frame: 12 and 26 weeks ]

8.  Secondary:   Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)   [ Time Frame: 26 weeks ]

9.  Secondary:   Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment   [ Time Frame: 12 and 26 weeks ]

10.  Secondary:   Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'   [ Time Frame: 26 weeks ]

11.  Secondary:   St Georges Respiratory Questionnaire for COPD   [ Time Frame: 12 and 26 weeks ]


  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



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01555138     History of Changes
Other Study ID Numbers: CQAB149B2401
2011-003732-31 ( EudraCT Number )
Study First Received: March 13, 2012
Results First Received: February 10, 2015
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration
Switzerland: Swiss Agency for Therapeutic Products
Columbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Argentina: National Administration of Drugs, Foods and Medical Technology - Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
Mexico: COFEPRIS - Comisión Federal para la Protección contra Riesgos Sanitarios.Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Malaysia: National Pharmaceutical Control BureauItalian Medicines Agency - AIFANetherlands: Centrale Commissie Mensgebonden Onderzoek -The Central Committee on Research Involving Human Subjects (CCMO)