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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)

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ClinicalTrials.gov Identifier: NCT01443845
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : January 25, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation Lung Diseases Respiratory Disorders Pulmonary Disease Chronic Obstructive Lung Diseases Chronic Obstructive Airway Disease Drug: Roflumilast Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)
Actual Study Start Date : September 30, 2011
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : January 31, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Roflumilast
 Drug: Roflumilast
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
Placebo Comparator: 2
Placebo
 Drug: Placebo
Dose-matched placebo, oral administration, once per day.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. [ Time Frame: Baseline to Week 52 ]
    Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.


Secondary Outcome Measures :
  1. Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

  2. Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.

  3. Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male or female patients at least 40 years of age
  • 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
  • 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
  • 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
  • 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
  • 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
  • 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

  • 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
  • 2. Known alpha-1-antitrypsin deficiency
  • 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
  • 4. Body mass index (BMI) ≥ 45 kg/m2
  • 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443845


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01443845    
Other Study ID Numbers: ROF-MD-07
First Posted: September 30, 2011    Key Record Dates
Results First Posted: January 25, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Keywords provided by AstraZeneca:
COPD
Exacerbations
Roflumilast
Daliresp
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases