Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA

Int J Chron Obstruct Pulmon Dis. 2018 May 3;13:1455-1468. doi: 10.2147/COPD.S159827. eCollection 2018.


Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 μg once-daily add-on therapy.

Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV1 was recorded at each time point.

Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all P<0.001]). Changes in CAT total score from baseline to Month 6 indicated that the average clinical impact of COPD was reduced from a severe (score: 21-30) to a moderate (score: 11-20) impairment. In DACOTA, mean change in post-bronchodilator FEV1 was 202 mL (P<0.001). Diarrhea, nausea, and weight decrease were the most frequently reported adverse drug reactions.

Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life.

Keywords: COPD assessment test; clinical COPD questionnaire; lung function; observational study; phosphodiesterase-4 inhibitor; quality of life; roflumilast.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Pragmatic Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aminopyridines / adverse effects
  • Aminopyridines / therapeutic use*
  • Benzamides / adverse effects
  • Benzamides / therapeutic use*
  • Bronchodilator Agents / adverse effects
  • Bronchodilator Agents / therapeutic use*
  • Cyclopropanes / adverse effects
  • Cyclopropanes / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Forced Expiratory Volume
  • Germany
  • Health Status
  • Humans
  • Lung / drug effects*
  • Lung / physiopathology
  • Male
  • Middle Aged
  • Phosphodiesterase 4 Inhibitors / adverse effects
  • Phosphodiesterase 4 Inhibitors / therapeutic use*
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive / diagnosis
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Quality of Life
  • Severity of Illness Index
  • Spirometry
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome


  • Aminopyridines
  • Benzamides
  • Bronchodilator Agents
  • Cyclopropanes
  • Phosphodiesterase 4 Inhibitors
  • Roflumilast