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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01329029




Registration number
NCT01329029
Ethics application status
Date submitted
30/03/2011
Date registered
5/04/2011
Date last updated
13/12/2016

Titles & IDs
Public title
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting ß2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
Scientific title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
Secondary ID [1] 0 0
2010-019685-87
Secondary ID [2] 0 0
RO-2455-404-RD
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Roflumilast
Treatment: Drugs - Placebo

Active Comparator: Roflumilast - concomitant medication: fixed combination of long-acting ß2-agonist and inhaled glucocorticosteroid

Placebo Comparator: Placebo - concomitant medication: fixed combination of long-acting ß2-agonist and inhaled glucocorticosteroid


Treatment: Drugs: Roflumilast
500 µg, once daily

Treatment: Drugs: Placebo
once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) - Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Rate of Severe COPD Exacerbations Per Patient Per Year - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Rate of COPD Exacerbations Per Patient Per Year All Categories - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Percentage of Participants Experiencing at Least 1 COPD Exacerbation - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Time to First COPD Exacerbation All Categories - Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Time to Second Moderate or Severe COPD Exacerbation - Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
Timepoint [6] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [7] 0 0
Time to Third Moderate or Severe COPD Exacerbation - Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
Timepoint [7] 0 0
52 Weeks
Secondary outcome [8] 0 0
Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year - The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)- Rate (Roflumilast 500 µg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.
Timepoint [8] 0 0
52 Weeks
Secondary outcome [9] 0 0
Number of Moderate or Severe COPD Exacerbation Days - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation - start date of exacerbation + 1) of all exacerbations within the category.
Timepoint [9] 0 0
52 Weeks
Secondary outcome [10] 0 0
Duration of Moderate or Severe COPD Exacerbations Per Participant - A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.
Timepoint [10] 0 0
52 Weeks
Secondary outcome [11] 0 0
Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC) - Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.
Timepoint [11] 0 0
52 weeks
Secondary outcome [12] 0 0
Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%) - Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.
Timepoint [12] 0 0
52 weeks
Secondary outcome [13] 0 0
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6) - FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.
Timepoint [13] 0 0
52 weeks
Secondary outcome [14] 0 0
Change From Baseline in Post-Bronchodilator FEV1/FVC - The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
Change From Baseline in Use of Rescue Medication From Daily Diary - Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.
Timepoint [15] 0 0
Baseline and Week 52
Secondary outcome [16] 0 0
Change From Baseline in COPD Symptom Score From Daily Diary - Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Percentage of Symptom-Free Days - Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.
Timepoint [17] 0 0
52 Weeks
Secondary outcome [18] 0 0
Percentage of Rescue Medication-Free Days - Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.
Timepoint [18] 0 0
52 Weeks
Secondary outcome [19] 0 0
Change From Baseline in COPD Assessment Test (CAT) Total Score - Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Percentage of Participants With Improvement in CAT - Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.
Timepoint [20] 0 0
Baseline and Week 52
Secondary outcome [21] 0 0
Time to Mortality Due to Any Reason During the Treatment Period Score - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [21] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [22] 0 0
Time to Mortality Due to COPD Exacerbation During the Treatment Period - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [22] 0 0
52 Weeks
Secondary outcome [23] 0 0
Time to Withdrawal During the Treatment Period - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [23] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [24] 0 0
Time to Withdrawal Due to COPD Exacerbation During the Treatment Period - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [24] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [25] 0 0
Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period - Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).
Timepoint [25] 0 0
52 Weeks
Secondary outcome [26] 0 0
Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period - Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [26] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [27] 0 0
Percentage of Participant With All-Cause Hospitalisation During the Treatment Period - Percentage of patients with at least one hospital admission due to any cause.
Timepoint [27] 0 0
52 Weeks
Secondary outcome [28] 0 0
Time to First Hospitalisation Due to Any Cause During the Treatment Period - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [28] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [29] 0 0
Time to Trial Withdrawal Due to an Adverse Event - Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day.
Timepoint [29] 0 0
52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)
Secondary outcome [30] 0 0
Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE) - An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Timepoint [30] 0 0
52 Weeks
Secondary outcome [31] 0 0
Change From Baseline in Body Weight - Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).
Timepoint [31] 0 0
Baseline and Week 52
Secondary outcome [32] 0 0
Change From Baseline in Body Mass Index (BMI) - Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.
Timepoint [32] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
- Giving written informed consent

- History of COPD (according to GOLD 2009) for at least 12 months prior to baseline
Visit V0 associated with chronic productive cough for 3 months in each of the 2 years
prior to baseline visit (with other causes of productive cough excluded)

- Age = 40 years

- Forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) ratio
(post-bronchodilator) < 70%

- FEV1 (post-bronchodilator) = 50% of predicted

- At least two documented moderate or severe COPD exacerbations within one year prior to
baseline visit

- Patients must be pre-treated with LABA and ICS for at least 12 months before baseline
Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA
and ICS are allowed, including changes in dose, active substances, and brands. In the
last 3 months before baseline Visit V0 patients must be pre-treated with fixed
combinations of LABA and ICS at a constant dose (maximum approved dosage strength of
the combination).

- Former smoker (defined as smoking cessation at least one year ago) or current smoker
both with a smoking history of at least 20 pack years

Main
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Exacerbations not resolved at first baseline visit

- Diagnosis of asthma and/or other relevant lung disease

- Known alpha-1-antitrypsin deficiency

- Other protocol-defined exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nycomed Investigational Site - Box Hill
Recruitment hospital [2] 0 0
Nycomed Investigational Site - Clayton
Recruitment hospital [3] 0 0
Nycomed Investigational Site - Concord
Recruitment hospital [4] 0 0
Nycomed Investigational site - Daws Park
Recruitment hospital [5] 0 0
Nycomed Investigational Site - Frankston
Recruitment hospital [6] 0 0
Nycomed Investigational Site - Heidelberg
Recruitment hospital [7] 0 0
Nycomed Investigational Site - Parkville
Recruitment hospital [8] 0 0
Nycomed Investigational Site - Toorak Gardens
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
5041 - Daws Park
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
5065 - Toorak Gardens
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Feldbach
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Halen
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Belgium
State/province [8] 0 0
Malmedy
Country [9] 0 0
Brazil
State/province [9] 0 0
Belo Horizonte
Country [10] 0 0
Brazil
State/province [10] 0 0
Botucatu
Country [11] 0 0
Brazil
State/province [11] 0 0
Florianópolis
Country [12] 0 0
Brazil
State/province [12] 0 0
Goiânia
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio de Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paolo
Country [16] 0 0
Brazil
State/province [16] 0 0
Vitória
Country [17] 0 0
Canada
State/province [17] 0 0
Hamilton
Country [18] 0 0
Canada
State/province [18] 0 0
Kingston
Country [19] 0 0
Canada
State/province [19] 0 0
Lachine
Country [20] 0 0
Canada
State/province [20] 0 0
Niagara Falls
Country [21] 0 0
Canada
State/province [21] 0 0
Richmond Hill
Country [22] 0 0
Canada
State/province [22] 0 0
Toronto
Country [23] 0 0
Canada
State/province [23] 0 0
Winnepeg
Country [24] 0 0
Denmark
State/province [24] 0 0
Hellerup
Country [25] 0 0
Denmark
State/province [25] 0 0
Hillerød
Country [26] 0 0
Denmark
State/province [26] 0 0
Hvidovre
Country [27] 0 0
Denmark
State/province [27] 0 0
København NV
Country [28] 0 0
France
State/province [28] 0 0
Férolles Attilly
Country [29] 0 0
France
State/province [29] 0 0
Nîmes
Country [30] 0 0
France
State/province [30] 0 0
Poitiers
Country [31] 0 0
France
State/province [31] 0 0
Saint-Laurent du Var
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Fürth
Country [35] 0 0
Germany
State/province [35] 0 0
Großhansdorf
Country [36] 0 0
Germany
State/province [36] 0 0
Hannover
Country [37] 0 0
Germany
State/province [37] 0 0
Homburg
Country [38] 0 0
Germany
State/province [38] 0 0
Koblenz
Country [39] 0 0
Germany
State/province [39] 0 0
Marburg
Country [40] 0 0
Germany
State/province [40] 0 0
Rüdersdorf
Country [41] 0 0
Greece
State/province [41] 0 0
Alexandroupolis
Country [42] 0 0
Greece
State/province [42] 0 0
Athens
Country [43] 0 0
Greece
State/province [43] 0 0
Heraklion, Crete
Country [44] 0 0
Greece
State/province [44] 0 0
Kavala
Country [45] 0 0
Greece
State/province [45] 0 0
Larissa
Country [46] 0 0
Greece
State/province [46] 0 0
Marousi
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Balassagyarmat
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Cegléd
Country [51] 0 0
Hungary
State/province [51] 0 0
Csorna
Country [52] 0 0
Hungary
State/province [52] 0 0
Deszk
Country [53] 0 0
Hungary
State/province [53] 0 0
Erd
Country [54] 0 0
Hungary
State/province [54] 0 0
Miskolc
Country [55] 0 0
Hungary
State/province [55] 0 0
Nyíregyháza
Country [56] 0 0
Hungary
State/province [56] 0 0
Pécs
Country [57] 0 0
Hungary
State/province [57] 0 0
Siófok
Country [58] 0 0
Hungary
State/province [58] 0 0
Sopron
Country [59] 0 0
Hungary
State/province [59] 0 0
Szombathely
Country [60] 0 0
Hungary
State/province [60] 0 0
Törökbálint
Country [61] 0 0
Israel
State/province [61] 0 0
Ashkelon
Country [62] 0 0
Israel
State/province [62] 0 0
Beer Sheva
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
Country [64] 0 0
Israel
State/province [64] 0 0
Holon
Country [65] 0 0
Israel
State/province [65] 0 0
Jerusalem
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalm
Country [67] 0 0
Israel
State/province [67] 0 0
Kfar Saba
Country [68] 0 0
Israel
State/province [68] 0 0
Petach Tikva
Country [69] 0 0
Israel
State/province [69] 0 0
Rehovot
Country [70] 0 0
Israel
State/province [70] 0 0
Tel Aviv
Country [71] 0 0
Israel
State/province [71] 0 0
Tel Hashomer
Country [72] 0 0
Israel
State/province [72] 0 0
Tel-Aviv
Country [73] 0 0
Italy
State/province [73] 0 0
Ferrara
Country [74] 0 0
Italy
State/province [74] 0 0
Genova
Country [75] 0 0
Italy
State/province [75] 0 0
Milano
Country [76] 0 0
Italy
State/province [76] 0 0
Modena
Country [77] 0 0
Italy
State/province [77] 0 0
Monza
Country [78] 0 0
Italy
State/province [78] 0 0
Pordenone
Country [79] 0 0
Italy
State/province [79] 0 0
Roma
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Anyang
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Cheongju
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Daegu
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Wonju
Country [85] 0 0
Netherlands
State/province [85] 0 0
's Hertogenbosch
Country [86] 0 0
Netherlands
State/province [86] 0 0
Amersfoort
Country [87] 0 0
Netherlands
State/province [87] 0 0
Arnhem
Country [88] 0 0
Netherlands
State/province [88] 0 0
Enschede
Country [89] 0 0
Netherlands
State/province [89] 0 0
Heerlen
Country [90] 0 0
Netherlands
State/province [90] 0 0
Hoorn
Country [91] 0 0
Poland
State/province [91] 0 0
Bialystok
Country [92] 0 0
Poland
State/province [92] 0 0
Bydgoszcz
Country [93] 0 0
Poland
State/province [93] 0 0
Gliwice
Country [94] 0 0
Poland
State/province [94] 0 0
Katowice
Country [95] 0 0
Poland
State/province [95] 0 0
Lodz
Country [96] 0 0
Poland
State/province [96] 0 0
Lublin
Country [97] 0 0
Poland
State/province [97] 0 0
Olesnica
Country [98] 0 0
Poland
State/province [98] 0 0
Ostrow Wielkopolski
Country [99] 0 0
Poland
State/province [99] 0 0
Tarnow
Country [100] 0 0
Poland
State/province [100] 0 0
Warszawa
Country [101] 0 0
Poland
State/province [101] 0 0
Wroclaw
Country [102] 0 0
Poland
State/province [102] 0 0
Zawadzkie
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Chelyabinsk
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Kazan
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Kemerovo
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Moscow
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Nizhniy Novgorod
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Novosibirsk
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Russian Federation
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the REACT trial is to investigate the effect of roflumilast 500 µg tablets
once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who
are concomitantly treated with a fixed combination of long-acting ß2-agonists (LABA) and
inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of
roflumilast will be obtained. An additional objective is to further characterize the
population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further
characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of
efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis
and a history of frequent exacerbations and must be concomitantly treated with a fixed
combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 µg once daily and
placebo) are included.
Trial website
https://clinicaltrials.gov/show/NCT01329029
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca AstraZeneca
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications