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Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

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ClinicalTrials.gov Identifier: NCT01533935
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Placebo
Drug: Tiotropium + Olodaterol
Drug: tiotropium + Olodaterol
Drug: Tiotropium
Drug: Olodaterol
Device: Respimat

  Participant Flow

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
This was a randomised, 4-period incomplete block cross-over trial. 291 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.

Reporting Groups
  Description
Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo

Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were

  • Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.
  • Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
  • Tiotropium fixed dose 5 µg
  • Olodaterol fixed dose 5 µg
Tio+Olo 5/5 / Tio / Olo / Placebo

Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were

  • Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
  • Tiotropium fixed dose 5 µg
  • Olodaterol fixed dose 5 µg
  • Oral inhalation of placebo
Tio / Olo / Placebo / Tio+Olo 2.5/5

Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were

  • Tiotropium fixed dose 5 µg
  • Olodaterol fixed dose 5 µg
  • Oral inhalation of placebo
  • Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5

Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were

  • Olodaterol fixed dose 5 µg
  • Oral inhalation of placebo
  • Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
  • Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio

Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were

  • Oral inhalation of placebo
  • Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
  • Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg
  • Tiotropium fixed dose 5 µg

Participant Flow:   Overall Study
    Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo   Tio+Olo 5/5 / Tio / Olo / Placebo   Tio / Olo / Placebo / Tio+Olo 2.5/5   Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5   Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio
STARTED   58   58   58   59   58 
Received Placebo   0   47   52   57   58 
Received Olo 5   52   52   55   59   0 
Received Tio 5   54   54   58   0   52 
Received Tio+Olo 2.5/5   58   0   49   56   56 
Received Tio+Olo 5/5   56   58   1 [1]   54   55 
COMPLETED   52 [2]   45 [2]   50 [2]   52 [2]   50 [2] 
NOT COMPLETED   6   13   8   7   8 
Adverse Event                5                7                1                5                3 
Protocol Violation                0                2                0                0                0 
Lost to Follow-up                0                0                1                0                0 
Withdrawal by Subject                0                4                5                2                4 
Other reason not defined above                1                0                1                0                1 
[1] One patient received Tio+Olo 5/5 instead of Tio+Olo 2.5/5 by mistake.
[2] All treatment periods



  Baseline Characteristics

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.
Treated Set (TS) : This patient set included all patients of the Randomised Set (RS : patients who signed the informed consent form and were also randomised, regardless of whether the patient was treated with study medication or not) who were dispensed study medication and were documented to have taken at least 1 dose of study medication.

Reporting Groups
  Description
Overall Study

A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:

  • Oral inhalation of placebo
  • Tiotropium fixed dose 5 µg
  • Olodaterol fixed dose 5 µg
  • Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg
  • Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg

Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence


Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 291 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (7.9) 
Gender 
[Units: Participants]
 
Female   87 
Male   204 


  Outcome Measures

1.  Primary:   Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity   [ Time Frame: 6 weeks ]

2.  Primary:   Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap   [ Time Frame: 6 weeks ]

3.  Secondary:   Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap   [ Time Frame: 6 weeks ]

4.  Secondary:   FEV1 (1 Hour Post-dose)   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01533935     History of Changes
Other Study ID Numbers: 1237.14
2011-004660-30 ( EudraCT Number: EudraCT )
First Submitted: February 13, 2012
First Posted: February 16, 2012
Results First Submitted: June 19, 2015
Results First Posted: September 15, 2015
Last Update Posted: September 15, 2015