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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01329029
First received: March 30, 2011
Last updated: June 16, 2014
Last verified: June 2014
  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:


Further study details as provided by Takeda:

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 ]

Enrollment: 1945
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 180 Study Locations
Sponsors and Collaborators
Takeda
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01329029     History of Changes
Other Study ID Numbers: RO-2455-404-RD, 2010-019685-87, U1111-1141-7422
Study First Received: March 30, 2011
Last Updated: June 16, 2014
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 Takeda:
COPD
Roflumilast
Daxas

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014