A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00622635
First received: February 4, 2008
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 Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 300 μg
Drug: Placebo to indacaterol
Drug: Salmeterol 50 μg

  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 300 μg - Placebo to Indacaterol - Salmeterol 50 μg In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Salmeterol 50 μg - Indacaterol 300 μg In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - Indacaterol 300 μg - Salmeterol 50 μg In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.
Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 for 3 periods

Period 1:   Treatment Period 1
    Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg     Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg     Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol     Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg     Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol     Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg  
STARTED     13     11     11     13     10     10  
COMPLETED     13     10     10     13     9     10  
NOT COMPLETED     0     1     1     0     1     0  
Adverse Event                 0                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0                 0                 0  
Abnormal test procedure result(s)                 0                 0                 0                 0                 1                 0  

Period 2:   Treatment Period 2
    Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg     Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg     Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol     Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg     Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol     Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg  
STARTED     13     10     10     13     9     10  
COMPLETED     12     10     10     13     9     10  
NOT COMPLETED     1     0     0     0     0     0  
Adverse Event                 1                 0                 0                 0                 0                 0  

Period 3:   Treatment Period 3
    Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg     Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg     Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol     Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg     Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol     Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg  
STARTED     12     10     10     13     9     10  
COMPLETED     12     10     10     10     9     10  
NOT COMPLETED     0     0     0     3     0     0  
Adverse Event                 0                 0                 0                 2                 0                 0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0  



  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
Entire Study Population The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  68  
Age  
[units: years]
Mean ± Standard Deviation
  65.6  ± 9.03  
Gender  
[units: participants]
 
Female     16  
Male     52  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: After 14 days ]

2.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 5 minutes post-dose at the end of each treatment period (Day 14) ]

3.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 15 minutes post-dose at the end of each treatment period (Day 14) ]

4.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 30 minutes post-dose at the end of each treatment period (Day 14) ]

5.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 1 hour post-dose at the end of each treatment period (Day 14) ]

6.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 2 hours post-dose at the end of each treatment period (Day 14) ]

7.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 3 hours post-dose at the end of each treatment period (Day 14) ]

8.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 4 hours post-dose at the end of each treatment period (Day 14) ]

9.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 5 hours post-dose at the end of each treatment period (Day 14) ]

10.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 6 hours post-dose at the end of each treatment period (Day 14) ]

11.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 8 hours post-dose at the end of each treatment period (Day 14) ]

12.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 10 hours post-dose at the end of each treatment period (Day 14) ]

13.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 11 hours 10 minutes post-dose at the end of each treatment period (Day 14) ]

14.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 11 hours 45 minutes post-dose at the end of each treatment period (Day 14) ]

15.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)   [ Time Frame: 14 hours post-dose at the end of each treatment period (Day 14) ]

16.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: 20 hours 10 minutes post-dose at the end of each treatment period (Day 15) ]

17.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: 20 hours 45 minutes post-dose at the end of each treatment period (Day 15) ]

18.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: 22 hours post-dose at the end of each treatment period (Day 15) ]

19.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: 23 hours 10 minutes post-dose at the end of each treatment period (Day 15) ]

20.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)   [ Time Frame: 23 hours 45 minutes post-dose at the end of each treatment period (Day 15) ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00622635     History of Changes
Other Study ID Numbers: CQAB149B2340
Study First Received: February 4, 2008
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products