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Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01543828
First received: February 28, 2012
Last updated: May 6, 2013
Last verified: May 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: indacaterol
Drug: placebo

  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 Then Placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Placebo Then Indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.

Participant Flow for 2 periods

Period 1:   Treatment 1
    Indacaterol Then Placebo     Placebo Then Indacaterol  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 2:   Treatment 2
    Indacaterol Then Placebo     Placebo Then Indacaterol  
STARTED     20     19 [1]
COMPLETED     19     19  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  
[1] 1 participant completed treatment 1, had an adverse event, and did not receive treatment 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 Then Placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
Placebo Then Indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Total Total of all reporting groups

Baseline Measures
    Indacaterol Then Placebo     Placebo Then Indacaterol     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean ± Standard Deviation
  62.2  ± 10.29     60.8  ± 6.90     61.5  ± 8.68  
Gender  
[units: participants]
     
Female     9     4     13  
Male     11     16     27  



  Outcome Measures

1.  Primary:   Time (in Minutes) to Patient's Perception of Onset of Effect   [ Time Frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2 ]


  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


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01543828     History of Changes
Other Study ID Numbers: CQAB149BUS01
Study First Received: February 28, 2012
Results First Received: March 19, 2013
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board