Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS) - Full Text View

Purpose

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 β2-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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Roflumilast Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Roflumilast

U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:

Rate of moderate or severe COPD exacerbations per patient per year [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-bronchodilator Forced Expiratory Volume in the First Second (FEV1) [L] [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Exacerbation analyses (time to event, proportion of patients experiencing a COPD exacerbation) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Forced vital capacity (FVC) [L] [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Forced expiratory flow at 25% to 75% of vital capacity (FEF25-75%) [L/s] [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Forced expiratory volume in the first 6 seconds (FEV6) [L] [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
FEV1/FVC [%] [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Use of rescue medication from daily diary [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
COPD symptom score from daily diary [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Incidences of Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Descriptive summary statistics of clinical laboratory values, ECG, vital signs including blood pressure and heart rate [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Changes in body weight [kg] and body mass index [kg/m2] [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1934
Study Start Date:	May 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Roflumilast concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid	Drug: Roflumilast 500 µg, once daily
Placebo Comparator: Placebo concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid	Drug: Placebo once daily

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination) for at least 12 months prior to baseline visit
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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329029

Contacts

Contact: Takeda Study Registration Call Center

+1-800-778-2860

medicalinformation@tpna.com

Show 180 Study Locations

Sponsors and Collaborators

Nycomed: A Takeda Company

More Information

No publications provided by Nycomed: A Takeda Company

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

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. Epub 2012 Jun 20.

Responsible Party:	Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:	NCT01329029 History of Changes
Other Study ID Numbers:	RO-2455-404-RD, 2010-019685-87
Study First Received:	March 30, 2011
Last Updated:	May 4, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Israel: Israeli Health Ministry Pharmaceutical Administration Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Nycomed: A Takeda Company:

COPD
Roflumilast
Daxas

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS) (REACT)