Pallav L Shah1, Zaid Zoumot2, Suveer Singh3, Stephen R Bicknell4, Ewen T Ross4, John Quiring5, Nicholas S Hopkinson6, Samuel V Kemp2. 1. The National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton, Harefield NHS Foundation Trust, and Imperial College, London, UK; Chelsea and Westminster Hospital, London, UK. Electronic address: pallav.shah@imperial.ac.uk. 2. The National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton, Harefield NHS Foundation Trust, and Imperial College, London, UK; Chelsea and Westminster Hospital, London, UK. 3. Chelsea and Westminster Hospital, London, UK. 4. Gartnavel General Hospital, Glasgow, UK. 5. QST Consultations Ltd, Allendale, MI, USA. 6. The National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton, Harefield NHS Foundation Trust, and Imperial College, London, UK.
Abstract
BACKGROUND: Few treatment options exist for patients with severe emphysema. We assessed the clinical benefits and safety of lung volume reduction coils (LVRCs) for the treatment of patients with severe emphysema with hyperinflation. METHODS: In a randomised study, we recruited patients with severe emphysema (aged ≥35 years) from three centres in the UK. Using a computer-generated randomisation sequence, we randomly allocated patients in a one-to-one ratio (block sizes of four and stratified by centre) to either LVRC treatment (treatment group) or best medical care (usual care group). The primary endpoint was the difference in response in the St George's Respiratory Questionnaire (SGRQ) between treatment and usual care groups at 90 days after final treatment (by intention-to-treat analysis). The trial is registered with ClinicalTrials.gov, number NCT01334307. FINDINGS:Between Jan 27, 2010, to Oct 25, 2011, we recruited and randomly allocated 47 patients: 23 to treatment and 24 to usual care (23 patients in each group were included in the intention-to-treat analysis). SGRQ response at 90 days after final treatment was greater in the treatment group than it was in the usual care group (between-group difference in change from baseline -8·36 points [95% CI -16·24 to -0·47]; p=0·04). We detected no between-group difference in serious adverse events. INTERPRETATION: Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation. FUNDING: PneumRx.
RCT Entities:
BACKGROUND: Few treatment options exist for patients with severe emphysema. We assessed the clinical benefits and safety of lung volume reduction coils (LVRCs) for the treatment of patients with severe emphysema with hyperinflation. METHODS: In a randomised study, we recruited patients with severe emphysema (aged ≥35 years) from three centres in the UK. Using a computer-generated randomisation sequence, we randomly allocated patients in a one-to-one ratio (block sizes of four and stratified by centre) to either LVRC treatment (treatment group) or best medical care (usual care group). The primary endpoint was the difference in response in the St George's Respiratory Questionnaire (SGRQ) between treatment and usual care groups at 90 days after final treatment (by intention-to-treat analysis). The trial is registered with ClinicalTrials.gov, number NCT01334307. FINDINGS: Between Jan 27, 2010, to Oct 25, 2011, we recruited and randomly allocated 47 patients: 23 to treatment and 24 to usual care (23 patients in each group were included in the intention-to-treat analysis). SGRQ response at 90 days after final treatment was greater in the treatment group than it was in the usual care group (between-group difference in change from baseline -8·36 points [95% CI -16·24 to -0·47]; p=0·04). We detected no between-group difference in serious adverse events. INTERPRETATION: Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation. FUNDING: PneumRx.
Authors: Carolyn E Come; Mordechai R Kramer; Mark T Dransfield; Muhanned Abu-Hijleh; David Berkowitz; Michela Bezzi; Surya P Bhatt; Michael B Boyd; Enrique Cases; Alexander C Chen; Christopher B Cooper; Javier Flandes; Thomas Gildea; Mark Gotfried; D Kyle Hogarth; Kumaran Kolandaivelu; William Leeds; Timothy Liesching; Nathaniel Marchetti; Charles Marquette; Richard A Mularski; Victor M Pinto-Plata; Michael A Pritchett; Samaan Rafeq; Edmundo R Rubio; Dirk-Jan Slebos; Grigoris Stratakos; Alexander Sy; Larry W Tsai; Momen Wahidi; John Walsh; J Michael Wells; Patrick E Whitten; Roger Yusen; Javier J Zulueta; Gerard J Criner; George R Washko Journal: Eur Respir J Date: 2015-04-02 Impact factor: 16.671