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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Rate of Severe COPD Exacerbations Per Patient Per Year
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Rate of COPD Exacerbations Per Patient Per Year All Categories
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Percentage of Participants Experiencing at Least 1 COPD Exacerbation
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Time to First COPD Exacerbation All Categories
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Time to Second Moderate or Severe COPD Exacerbation
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
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
Timepoint [8] 0 0
52 Weeks
Secondary outcome [9] 0 0
Number of Moderate or Severe COPD Exacerbation Days
Timepoint [9] 0 0
52 Weeks
Secondary outcome [10] 0 0
Duration of Moderate or Severe COPD Exacerbations Per Participant
Timepoint [10] 0 0
52 Weeks
Secondary outcome [11] 0 0
Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)
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%)
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)
Timepoint [13] 0 0
52 weeks
Secondary outcome [14] 0 0
Change From Baseline in Post-Bronchodilator FEV1/FVC
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
Change From Baseline in Use of Rescue Medication From Daily Diary
Timepoint [15] 0 0
Baseline and Week 52
Secondary outcome [16] 0 0
Change From Baseline in COPD Symptom Score From Daily Diary
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Percentage of Symptom-Free Days
Timepoint [17] 0 0
52 Weeks
Secondary outcome [18] 0 0
Percentage of Rescue Medication-Free Days
Timepoint [18] 0 0
52 Weeks
Secondary outcome [19] 0 0
Change From Baseline in COPD Assessment Test (CAT) Total Score
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Percentage of Participants With Improvement in CAT
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
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
Timepoint [22] 0 0
52 Weeks
Secondary outcome [23] 0 0
Time to Withdrawal During the Treatment Period
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
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
Timepoint [25] 0 0
52 Weeks
Secondary outcome [26] 0 0
Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period
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
Timepoint [27] 0 0
52 Weeks
Secondary outcome [28] 0 0
Time to First Hospitalisation Due to Any Cause During the Treatment Period
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
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)
Timepoint [30] 0 0
52 Weeks
Secondary outcome [31] 0 0
Change From Baseline in Body Weight
Timepoint [31] 0 0
Baseline and Week 52
Secondary outcome [32] 0 0
Change From Baseline in Body Mass Index (BMI)
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
Sex
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
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
1945
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
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Sopron
Country [59] 0 0
Hungary
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Szombathely
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Hungary
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Törökbálint
Country [61] 0 0
Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [64] 0 0
Holon
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Israel
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Jerusalem
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalm
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Monza
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Italy
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Pordenone
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Italy
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Roma
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Korea, Republic of
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Anyang
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Korea, Republic of
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Cheongju
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju
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Netherlands
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's Hertogenbosch
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Netherlands
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Amersfoort
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Arnhem
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Netherlands
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Enschede
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Netherlands
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Heerlen
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Netherlands
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Hoorn
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Gliwice
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Katowice
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Lodz
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Lublin
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Olesnica
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Ostrow Wielkopolski
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Tarnow
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Warszawa
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Wroclaw
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Zawadzkie
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Volgograd
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yaroslavl
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Slovakia
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Banska Bystrica
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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South Africa
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Auckland Park, Johannesburg Gauteng
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South Africa
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Benoni Gauteng
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South Africa
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Bloemfontein Free State
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South Africa
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Cape Town Western Cape
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South Africa
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Durban Kwazulu-Natal
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South Africa
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Johannesburg
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South Africa
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Morningside, Johannesburg Gauteng
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South Africa
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Thabazimbi Limpopo
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South Africa
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Umkomaas Kwazulu-Natal
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South Africa
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Witbank Mpumalanga
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Spain
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Barcelona
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Spain
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Guadalajara
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Spain
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Madrid
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Spain
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Pozuelo de Alarcon
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Spain
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Santander
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Spain
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Terrassa
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Spain
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Valencia
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Turkey
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Ankara
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Turkey
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Canakkale
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Mersin
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
State/province [153] 0 0
Norwich

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01329029