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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
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Feldbach
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Austria
State/province [2] 0 0
Graz
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Austria
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Salzburg
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Austria
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Wien
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Bruxelles
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Halen
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Belgium
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Liege
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Belgium
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Malmedy
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Florianópolis
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Goiânia
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Rio de Janeiro
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Sao Paolo
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Vitória
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Canada
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Hamilton
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Kingston
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Lachine
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Niagara Falls
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Canada
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Richmond Hill
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Canada
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Toronto
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Canada
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Winnepeg
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Denmark
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Hellerup
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Nîmes
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Germany
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Fürth
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Koblenz
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Durban Kwazulu-Natal
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South Africa
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Morningside, Johannesburg Gauteng
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South Africa
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Umkomaas Kwazulu-Natal
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South Africa
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Spain
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Barcelona
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Guadalajara
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Madrid
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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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Konya
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Mersin
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United Kingdom
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Edinburgh
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Glasgow
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United Kingdom
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Liverpool
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London
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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/study/NCT01329029
Trial related presentations / publications
Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4.
Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.
Rabe KF, Calverley PMA, Martinez FJ, Fabbri LM. Effect of roflumilast in patients with severe COPD and a history of hospitalisation. Eur Respir J. 2017 Jul 5;50(1):1700158. doi: 10.1183/13993003.00158-2017. Print 2017 Jul. No abstract available.
Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13.
Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. doi: 10.2147/COPD.S31100. Epub 2012 Jun 20.
Public notes

Contacts
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AstraZeneca AstraZeneca
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AstraZeneca
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01329029