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.