Pneumologie 2018; 72(S 01): S84
DOI: 10.1055/s-0037-1619342
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: COPD I
Georg Thieme Verlag KG Stuttgart · New York

Indacaterol/glycopyrronium (IND/GLY) reduces the risk of clinically important deterioration (CID) in patients with moderate COPD: Results from the CRYSTAL study

T Greulich
1   Schwerpunkt Pneumologie, Klinik für Innere Medizin, Universitätsklinikum Gießen und Marburg, Standort Marburg
,
K Kostikas
2   Novartis Pharma AG, Basel
,
M Gaga
3   7th Respiratory Medicine Department, Athens Chest Hospital Sotiria
,
M Aalamian-Mattheis
2   Novartis Pharma AG, Basel
,
F Patalano
2   Novartis Pharma AG, Basel
,
X Nunez
4   TFS Develop, Barcelona
,
VA Pagano
4   TFS Develop, Barcelona
,
A Clemens
2   Novartis Pharma AG, Basel
,
R Fogel
5   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
C Vogelmeier
6   Pulmonary and Critical Care Medicine, Philipps-Universität Marburg
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 
 

    Introduction:

    Decline in health status, lung function, and exacerbations are important determinants of disease progression of COPD patients. CID has been proposed as a composite endpoint to evaluate COPD treatment effects. We report the effect of IND/GLY on CID in patients with moderate COPD, after direct switch from LABA+ICS, or a LABA or a LAMA monotherapy.

    Methods:

    CRYSTAL, a 12-week, prospective, multicentre, randomised, open-label, pragmatic trial, evaluated the effect of IND/GLY or GLY after a direct switch from previous treatments in moderate COPD patients. CID was defined as a ≥100 mL decrease in trough FEV1 or a ≥1 point decrease in transition dyspnoea index (TDI) or a ≥0.4 point increase in clinical COPD questionnaire (CCQ) score or a moderate/severe exacerbation.

    Results:

    Of 2,159 patients analysed in the IND/GLY treatment arms, 1,622 switched to IND/GLY and 537 continued their baseline treatment. The percentage of patients experiencing a CID was significantly lower in patients who switched to IND/GLY vs. patients who continued on LABA+ICS, or on a LABA or a LAMA, using different CID definitions (Table). Subgroup analyses according to different baseline characteristics were consistent with the overall results.

    Tab. 1:

    Proportion of patients experiencing CID (ITT set)

    Composite CID

    Baseline treatment:

    LABA+ICS

    (N = 1080)

    Baseline treatment:

    LABA or LAMA

    (N = 1079)

    LABA+ICS

    (n = 269)

    IND/GLY

    (110/50 µg o.d.)

    (n = 811)

    LABA or LAMA

    (n = 268)

    IND/GLY

    (110/50µg o.d.)

    (n = 811)

    FEV1 or

    TDI or

    moderate/severe

    AECOPD

    n (%)

    91 (33.8)

    226 (27.9)

    114 (42.5)

    188 (23.2)

    OR (95% CI)

    of patients

    deteriorating

    0.76

    (0.56, 1.02)

    0.41*

    (0.30, 0.55)

    FEV1, or

    CCQ or

    moderate/severe

    AECOPD

    n (%)

    104 (38.7)

    260 (32.1)

    123 (45.9)

    210 (25.9)

    OR (95% CI)

    of patients

    deteriorating

    0.75*

    (0.56, 1.00#)

    0.41*

    (0.31, 0.55)

    FEV1 or

    TDI or

    CCQ or

    moderate/severe

    AECOPD

    n (%)

    121 (45.0)

    288 (35.5)

    142 (53.0)

    248 (30.6)

    OR (95% CI)

    of patients

    deteriorating

    0.67*

    (0.51, 0.89)

    0.39*

    (0.29, 0.52)

    * Statistically significant differences, #Derived after round-off, actual value of upper limit of 95% CI is 0.9968 AECOPD, acute exacerbation of COPD; CCQ, clinical COPD questionnaire; CI, confidence interval FEV1, forced expiratory volume in 1 second; TDI, transition dyspnoea index; IND/GLY, indacaterol/glycopyrronium; ITT, intent-to-treat; LABA+ICS, long-acting (β2 agonist+inhaled corticosteroid; LAMA, long-acting muscarinic antagonist, o.d., once daily, OR; odds ratio

    Conclusion:

    Indacaterol/glycopyrronium significantly reduced the risk of CID in moderate COPD patients, after direct switch from LABA/ICS, or a LABA or a LAMA.


    #