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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01329029
First received: March 30, 2011
Last updated: May 23, 2013
Last verified: May 2013

March 30, 2011
May 23, 2013
May 2011
May 2014   (final data collection date for primary outcome measure)
Rate of moderate or severe COPD exacerbations per patient per year [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01329029 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Roflumilast
    500 µg, once daily
  • Drug: Placebo
    once daily
  • Active Comparator: Roflumilast
    concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid
    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo
    concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1940
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Turkey,   United Kingdom
 
NCT01329029
RO-2455-404-RD, 2010-019685-87, U1111-1141-7422
No
Takeda
Takeda
Not Provided
Not Provided
Takeda
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP