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Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: March 16, 2017
Last verified: March 2017
Results First Received: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: COPD
COPD Exacerbation
Lung Diseases
Respiratory Disorders
Pulmonary Disease
Chronic Obstructive Lung Diseases
Chronic Obstructive Airway Disease
Interventions: Drug: Roflumilast
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
Recruitment occurred from September 2011 to October 2014 for a total of 380 study centers screened patients for the study: Italy, Spain, United States, Ukraine, Argentina, Russia, Philippines, Romania, Serbia, Canada, Malaysia, Thailand, Mexico, Peru and Taiwan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of 2 weeks of single-blind placebo lead-in with fixed-dose combination (FDC) long-acting β2-agonist(s) (LABA)/inhaled corticosteroid(s) (ICS) treatment followed by 52 weeks of double-blind treatment in addition to maintenance FDC LABA/ICS.

Reporting Groups
  Description
Placebo Dose-matched placebo, oral administration, once per day.
Roflumilast Roflumilast 500 µg, oral administration, once per day

Participant Flow:   Overall Study
    Placebo   Roflumilast
STARTED   1176   1178 
COMPLETED   922   841 
NOT COMPLETED   254   337 
Protocol Violation                43                45 
Other reasons, such as COPD exacerbation                44                44 
Deterioration in pulmonary function                1                4 
Lack of Efficacy                10                5 
Adverse Event                64                138 
Withdrawal by Subject                63                67 
Military Conflict - Site Terminated                20                21 
Lost to Follow-up                9                13 



  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.
The demographic information provided here is for the safety population. The safety population (numbering 2352 patients) of the trial does not include 2 patients from the enrolled population (numbering 2354 patients), due to a protocol deviation for one patient and an adverse event for a second patient, both in the placebo arm

Reporting Groups
  Description
Placebo Dose-matched placebo, oral administration, once per day.
Roflumilast Roflumilast 500 µg, oral administration, once per day
Total Total of all reporting groups

Baseline Measures
   Placebo   Roflumilast   Total 
Overall Participants Analyzed 
[Units: Participants]
 1174   1178   2352 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (8.4)   64.4  (8.8)   64.5  (8.6) 
Age, Customized 
[Units: Participants]
     
Adults 40-65 years   634   640   1274 
Adults over 65 years   540   538   1078 
Sex/Gender, Customized 
[Units: Participants]
     
Male   794   821   1615 
Female   380   357   737 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   944   935   1879 
Black or African American   27   35   62 
Asian   170   167   337 
American Indian or Alaska Native   6   16   22 
Native Hawaiian or Other Pacific Islander   0   2   2 
Other   27   23   50 
Region of Enrollment 
[Units: Participants]
     
Colombia   7   10   17 
Argentina   197   198   395 
Russian Federation   77   77   154 
Romania   55   54   109 
United States   458   457   915 
Philippines   130   131   261 
Ukraine   95   95   190 
Malaysia   6   7   13 
Thailand   18   16   34 
Spain   6   6   12 
Canada   14   15   29 
Taiwan   7   6   13 
Italy   0   1   1 
Mexico   22   22   44 
Serbia   47   47   94 
Peru   35   36   71 
Ethnicity 
[Units: Participants]
     
Hispanic or Latino   272   268   540 
Not Hispanic or Latino   902   910   1812 
ICS/LABA Therapy 
[Units: Participants]
     
Advair   766   768   1534 
Symbicort   408   410   818 
Long-acting muscarinic antagonist(s) (LAMA) use 
[Units: Participants]
     
LAMA   546   548   1094 
No-LAMA   628   630   1258 
BMI Category 
[Units: Participants]
     
Under weight: < 18.5   95   100   195 
Normal weight: >= 18.5 to < 25   480   468   948 
Over weight: >= 25 to < 30   347   342   689 
Obese: >= 30   252   268   520 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 72.57  (18.67)   73.63  (19.57)   73.10  (19.13) 
Height 
[Units: Cm]
Median (Standard Deviation)
 167.53  (9.39)   167.80  (9.35)   167.67  (9.37) 
Body-Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.72  (5.72)   25.99  (5.91)   25.86  (5.82) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.   [ Time Frame: Baseline to Week 52 ]

2.  Secondary:   Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)   [ Time Frame: Week 0 (Visit 2) to Week 52 ]

3.  Secondary:   Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics   [ Time Frame: Week 0 (Visit 2) to Week 52 ]

4.  Secondary:   Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Week 0 (Visit 2) to Week 52 ]


  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: AstraZeneca Clinical Study Information Center
Organization: AstraZeneca
phone: 1-877-240-9479
e-mail: information.center@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01443845     History of Changes
Other Study ID Numbers: ROF-MD-07
Study First Received: September 28, 2011
Results First Received: November 30, 2016
Last Updated: March 16, 2017