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4. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, Herrick, Ariane L, Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, and Herrick, Ariane L

Abstract

OBJECTIVE Our objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP. METHODS Patients with systemic sclerosis (SSc) and ≥7 RP attacks during the last screening week prior to a baseline visit were randomised to four weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud’s Condition Score, with change in RP attacks/week as primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory endpoints included patients’ and physicians’ global impression of change, Assessment of Scleroderma-associated Raynaud’s Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites. RESULTS Sixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). Mean weekly number of RP attacks (baseline; vipoglanstat 14.4[SD 6.7], placebo 18.2[12.6]) decreased by 3.4[95% CI -5.8;-1.0] and 4.2[-6.5;-2.0] attacks per week (p= 0.628) respectively. All patient reported outcomes improved, with no difference between the groups. Mean change in recovery of peripheral blood flow after cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in urine. Vipoglanstat was safe and well tolerated. CONCLUSION Although vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.

Published
2024

5. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, primary, Edenius, Charlotte, additional, Pauling, John D, additional, Denton, Christopher P, additional, Olsson, Anna, additional, Kowalski, Jan, additional, Murray, Andrea, additional, Anderson, Marina, additional, Bhat, Smita, additional, Del Galdo, Francesco, additional, Hall, Frances, additional, Korkosz, Mariusz, additional, Krasowska, Dorota, additional, Olas, Jacek, additional, Smith, Vanessa, additional, van Laar, Jacob M, additional, Vonk, Madelon C, additional, Wojteczek, Anna, additional, and Herrick, Ariane L, additional

Published
2024
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7. An open-label, pharmacodynamic trial investigating vascular effects of the angiotensin II type 2 receptor (AT2R) agonist (ATRAG) C21

Author

Ganslandt, Cecilia, primary, Rein-Hedin, Erik, additional, Sjöberg, Folke, additional, Tornling, Göran, additional, Bengtsson, Thomas, additional, Overbeck, Kamilla, additional, Rosendahl, Elin, additional, Batta, Rohit, additional, Bjerring, Barbara, additional, Raud, Johan, additional, and Dalsgaard, Carl-Johan, additional

Published
2023
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11. A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud's.

Author

Herrick, Ariane L, Batta, Rohit, Overbeck, Kamilla, Raud, Johan, Manning, Joanne, Murray, Andrea, Dinsdale, Graham, and Tornling, Göran

Subjects
RAYNAUD'S disease, DRUG efficacy, BODY temperature, FINGERS, SYSTEMIC scleroderma, RANDOMIZED controlled trials, BLIND experiment, ANALYSIS of covariance, DESCRIPTIVE statistics, RESEARCH funding, ANGIOTENSIN receptors, VASOCONSTRICTION, STATISTICAL sampling, CROSSOVER trials, MEDICAL thermography, DISEASE complications, EVALUATION
Abstract

Objective Our main aim was to investigate the effect of a single oral dose of C21, a selective angiotensin II type 2 receptor agonist, on cold-induced vasoconstriction in SSc-related RP. Methods This was a phase IIa, randomized, double-blind, cross-over, single-dose, placebo-controlled, single-centre study. Twelve female patients with SSc (median age 58.5 years, median duration of RP 19.0 years) attended on four occasions: screening, treatment visits 1 and 2 (separated by 3–7 days) and follow-up. At the first treatment visit, patients were randomized to receive either a single oral dose of C21 (200 mg) or placebo, then the opposite treatment on the second visit. Forty min after each treatment, each patient underwent a standard hand cold challenge. The primary end point was the area under the curve (AUC) for rewarming for each finger (eight fingers) over 15 min. Secondary end points included the maximum finger temperature after rewarming (MAX). Statistical analyses were performed by multiplicative ANCOVA models. Results For all eight fingers combined, mean AUC for rewarming was higher after treatment with C21 than after placebo (geometric mean 20 046°C*s vs 19 558°C*s), but not significantly (P  = 0.380) and MAX (at 15 min) was also higher (geometric mean 23.5°C vs 22.5°C; P  = 0.036). C21 was well tolerated. Conclusion Despite the small trial size, a signal emerged suggesting that even in patients with established SSc, C21 may confer benefit for RP and deserves further investigation. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov , NCT04388176. [ABSTRACT FROM AUTHOR]

Published
2023
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13. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

Author

Saketkoo, Lesley Ann, Mittoo, Shikha, Huscher, Dörte, Khanna, Dinesh, Dellaripa, Paul F, Distler, Oliver, Flaherty, Kevin R, Frankel, Sid, Oddis, Chester V, Denton, Christopher P, Fischer, Aryeh, Kowal-Bielecka, Otylia M, LeSage, Daphne, Merkel, Peter A, Phillips, Kristine, Pittrow, David, Swigris, Jeffrey, Antoniou, Katerina, Baughman, Robert P, Castelino, Flavia V, Christmann, Romy B, Christopher-Stine, Lisa, Collard, Harold R, Cottin, Vincent, Danoff, Sonye, Highland, Kristin B, Hummers, Laura, Shah, Ami A, Kim, Dong Soon, Lynch, David A, Miller, Frederick W, Proudman, Susanna M, Richeldi, Luca, Ryu, Jay H, Sandorfi, Nora, Sarver, Catherine, Wells, Athol U, Strand, Vibeke, Matteson, Eric L, Brown, Kevin K, Seibold, James R, Aggarwal, Rohit, Ainslie, Gillian, Alkassab, Firas, Allanore, Yannick, Descartes, Paris, Anderson, Marina E, Andonopoulos, Andrew P, Antin-Ozerkis, Danielle, Arrobas, Ana, Ascherman, Dana P, Assassi, Shervin, Baron, Murray, Bathon, Joan M, Behr, Juergen, Beretta, Lorenzo, Bingham, Clifton O, III, Binnie, Matthew, Birring, Surinder S, Boin, Francesco, Bongartz, Tim, Bourdin, Arnaud, Bouros, Demosthenes, Brasington, Richard, Bresser, Paul, Buch, Maya H, Burge, P Sherwood, Carmona, Loreto, Carreira, Patricia E, Carvalho, Carlos RR, Catoggio, Luis J, Chan, Kevin M, Chapman, Jeffrey, Chatterjee, Soumya, Chua, Felix, Chung, Lorinda, Conron, Matthew, Corte, Tamera, Cosgrove, Gregory, Costabel, Ulrich, Cox, Gerard, Crestani, Bruno, Crofford, Leslie J, Csuka, Mary E, Curbelo, Pablo, László, Czirják, Daniil, Zoe, DʼArsigny, Christine L, Davis, Gerald S, de Andrade, Joao A, De Vuyst, Paul, Dempsey, Owen J, Derk, Chris T, Distler, Jörg, Dixon, William G, Downey, Gregory, Doyle, Mittie K, Drent, Marjolein, Durairaj, Lakshmi, Emery, Paul, Espinoza, Luis R, Farge, Dominique, Fathi, Maryam, Fell, Charlene D, Fessler, Barri J, Fitzgerald, John E, Fox, George A, Foeldvari, Ivan, Frech, Tracy M, Freitas, Sara, Furst, Daniel E, Gabrielli, Armando, García-Vicuña, Rosario, Georgiev, Ognian B, Gerbino, Anthony, Gillisen, Adrian, Gladman, Dafna D, Glassberg, Marilyn, Gochuico, Bernadette R, Gogali, Athena, Goh, Nicole S, Goldberg, Avram, Goldberg, Hilary J, Gourley, Mark F, Griffing, Leroy, Grutters, Jan C, Gunnarsson, Ragnar, Hachulla, Eric, Hall, Frances C, Harari, Sergio, Herrick, Ariane L, Herzog, Erica L, Hesselstrand, Roger, Hirani, Nikhil, Hodgson, Ulla, Hollingsworth, Helen M, Homer, Robert J, Hoyles, Rachel K, Hsu, Vivien M, Hubbard, Richard B, Hunzelmann, Nicolas, Isasi, Maria Eloisa, Isasi, Elida Susana, Sergio A Jimenez, Jacobsen Soren, Johnson, Sindhu R, Jones, Christine H, Kahaleh, Bashar, Kairalla, Ronaldo A, Kalluri, Meena, Kalra, Sanjay, Kaner, Robert J, Kinder, Brent W, Klingsberg, Ross C, Kokosi, Maria, RJ Kolb, Martin, Kur-Zalewska, Joanna, Kuwana, Masataka, Lake, Fiona R, Lally, Edward V, Lasky, Joseph A, Laurindo, Ileda M, Able, Lawrence, Lee, Peter, Leonard, Colm T, Lien, Dale C, Limper, Andrew H, Liossis, Stamatis-Nick C, Lohr, Kristine M, Loyd, James E, Lundberg, Ingrid E, Mageto, Yolanda N, Maher, Toby M, Mahmud, Tafazzul H, Manganas, Helene, Marie, Isabelle, Marras, Theodore K, Antônio Baddini Martinez, José, Martinez, Fernando J, Mathieu, Alessandro, Matucci-Cerinic, Marco, Mayes, Maureen D, McKown, Kevin M, Medsger, Thomas A, Jr., Meehan, Richard T, Cristina, Mendes Ana, Meyer, Keith C, Millar, Ann B, Moğulkoç, Nesrin, Molitor, Jerry A, Morais, António, Luc Mouthon, Portugal, Müller, Veronika, Müller-Quernheim, Joachim, Nadashkevich, Oleg, Nador, Roland, Nash, Peter, Nathan, Steven D, Navarro, Carmen, Neves, Sofia, Noth, Imre, Nunes, Hilario, Olson, Amy L., Opitz, Christian F, Padilla, Maria, Pappas, Dimitrios, Parfrey, Helen, Pego-Reigosa, José M, AC Pereira, Carlos, Perez, Rafael, Pope, Janet E, Porter, Joanna C., Renzoni, Elisabeth A, Riemekasten, Gabriela, Riley, David J, Rischmueller, Maureen, Rodriguez-Reyna, Tatiana S, Rojas-Serrano, Romam, Jesse, Rosen, Glenn D, Rossman, Milton, Rothfield, Naomi, Sahn, Steven A, Sanduzzi, Alessandro, Scholand, Mary Beth, Selman, Moises, Senécal, Jean-Luc, Seo, Philip, Silver, Richard M, Solomon, Joshua J, Steen, Virginia, Stevens, Wendy, Strange, Charlie, Sussman, Robert, Sutton, Evelyn D, Sweiss, Nadera J, Tornling, Göran, Tzelepis, George E, Undurraga, Alvaro, Vacca, Allessandra, Vancheri, Carlo, Varga, Janos, Veale, Douglas J, Volkov, Suncica, Walker, Ulrich A, Wencel, Mark, Wesselius, Lewis J, Wickremasinghe, Melissa, Wilcox, Pearce, Wilsher, Margaret L, Wollheim, Frank A, Wuyts, Wim A, Yung, Gordon, Zanon, Pietro, Zappala, Christopher J, Groshong, Steve D, Leslie, Kevin O, Myers, Jeffrey L, Padera, Robert F, R Desai, Sujal, Goldin, Jonathan, Kazerooni, Ella A, Klein, Jeffrey S, Lynch, David A, and Keen, Kevin J

Published
2014
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14. The angiotensin type 2 receptor agonist C21 restores respiratory function in COVID19 - a double-blind, randomized, placebo-controlled Phase 2 trial

Author

Tornling, Göran, primary, Batta, Rohit, additional, Porter, Joanna, additional, Bengtsson, Thomas, additional, Parmar, Kartikeya, additional, Kashiva, Reema, additional, Hallberg, Anders, additional, Cohrt, Anne Katrine, additional, Westergaard, Kate, additional, Dalsgaard, Carl-Johan, additional, and Raud, Johan, additional

Published
2021
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15. Seven Days Treatment With the Angiotensin II Type 2 Receptor Agonist C21 in Hospitalized COVID-19 Patients: A Placebo-Controlled Randomized Phase 2 Trial

Author

Tornling, Göran, primary, Batta, Rohit, additional, Porter, Joanna C., additional, Williams, Bryan, additional, Bengtsson, Thomas, additional, Parmar, Kartikeya, additional, Kashiva, Reema, additional, Hallberg, Anders, additional, Cohrt, Anne Katrine, additional, Westergaard, Kate, additional, Dalsgaard, Carl-Johan, additional, and Raud, Johan, additional

Published
2021
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26. Tenascin-C and alpha-smooth muscle actin positive cells are increased in the large airways in patients with COPD

Author

Tornling Göran, Lappi-Blanco Elisa, Kaarteenaho Riitta, Löfdahl Magnus, and Sköld Magnus C

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Abstract Background Chronic obstructive pulmonary disease (COPD) is characterized by inflammation and remodeling of the lungs. This results in alterations in extracellular matrix (ECM) and structural changes leading to airflow obstruction. We studied the expression of tenascin-C (Tn-C) and alpha smooth muscle actin (α-SMA), which act as a marker of myofibroblasts, in large airways from COPD patients. Our aim was to elucidate whether this expression correlated with smoking or with disease development. Methods Bronchoscopy was performed on 20 COPD patients (mean age 56 years; range 39-61; FEV1/FVC < 70% and FEV1 median 53% (range 33-69) of predicted). Age and smoking matched smokers (S) without COPD (n = 13) and age matched non-smokers (NS) (n = 14) served as controls. Bronchial mucosal biopsies were analyzed by immunohistochemistry. The distribution of Tn-C expression was assessed and graded in three levels, and the number of spindle shaped cells staining positive for α-SMA were counted. Results Biopsies from COPD patients had more (P < 0.001) Tn-C expression than the two control groups. A significantly (P < 0.05) increased number of spindle shaped cells expressing α-SMA was observed in COPD patients compared with the controls. Smokers and nonsmokers did not differ in this respect. The expression of Tn-C correlated positively (P < 0.001) to the number of α-SMA positive cells. Conclusions We demonstrate increased expression of Tn-C and α-SMA positive cells in the large airways in COPD. This was not associated to smoking per se, but to the presence of airway obstruction. Our findings add new information regarding remodeling characteristics and highlight the large airways as a potential site for airways obstruction in COPD.

Published
2011
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27. Respiratory Diseases as Risk Factors for Seropositive and Seronegative Rheumatoid Arthritis and in Relation to Smoking.

Author

Kronzer, Vanessa L., Westerlind, Helga, Alfredsson, Lars, Crowson, Cynthia S., Nyberg, Fredrik, Tornling, Göran, Klareskog, Lars, Holmqvist, Marie, and Askling, Johan

Subjects
RHEUMATOID arthritis risk factors, AUTOANTIBODIES, CONFIDENCE intervals, IMMUNOGLOBULINS, RESPIRATORY diseases, RISK assessment, SMOKING, LOGISTIC regression analysis, ENVIRONMENTAL exposure, ODDS ratio
Abstract

Objective: The link and interplay between different airway exposures and rheumatoid arthritis (RA) risk are unclear. This study was undertaken to determine whether respiratory disease is associated with development of RA, and specifically to examine this relationship by RA serostatus and smoking exposure. Methods: Using data from the Epidemiological Investigation of Rheumatoid Arthritis study, this analysis included 1,631 incident RA cases and 3,283 matched controls recruited from 2006 to 2016. Linking these individuals to the National Patient Register provided information on past acute or chronic, upper or lower respiratory disease diagnoses. For each disease group, we estimated adjusted odds ratios (ORadj) with 95% confidence intervals (95% CI) for RA, using logistic regression models adjusted for age, sex, residential area, body mass index, and education both overall and stratified by anti–citrullinated protein antibody (ACPA)/rheumatoid factor (RF) status and by smoking status. Results: Respiratory disease diagnoses were associated with risk of RA, with an ORadj of 1.2 for acute upper respiratory disease (95% CI 0.8–1.7), 1.4 for chronic upper respiratory disease (95% CI 1.1–1.9), 2.4 for acute lower respiratory disease (95% CI 1.5–3.6), and 1.6 for chronic lower respiratory disease (95% CI 1.5–3.6). These associations were present irrespective of RF or ACPA status, though the association was somewhat stronger for ACPA/RF–positive than ACPA/RF–negative RA. The association between any respiratory disease and RA was stronger for nonsmokers (ORadj 2.1 [95% CI 1.5–2.9]) than for smokers (ORadj 1.2 [95% CI 0.9–1.5]). Conclusion: Respiratory diseases increase the risk for both seropositive and seronegative RA, but only among nonsmokers. These findings raise the hypothesis that smoking and airway disease are associated with RA development through partly different mechanisms. [ABSTRACT FROM AUTHOR]

Published
2021
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38. Detection of Chlamydia pneumoniae on cytospin preparations from bronchoalveolar lavage in COPD patients and in lung tissue from advanced emphysema

Author

Brandén, Eva, Gnarpe, Judy, Hillerdal, Gunnar, Orre, Lotta, Sköld, C Magnus, Löfdahl, Magnus, Koyi, Hirsh, and Tornling, Göran

Subjects
lung tissue, Male, Sweden, Cytodiagnosis, cytospin, respiratory system, Chlamydophila pneumoniae, Middle Aged, Bronchoalveolar Lavage, respiratory tract diseases, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Chlamydia pneumoniae, COPD, Humans, Female, Lung, Original Research
Abstract

Chronic obstructive pulmonary disease (COPD) is associated with smoking but other etiological factors contribute. Chlamydia pneumoniae is an obligate intracellular bacterium causing both acute and chronic respiratory tract infections. Studies have revealed an association between chronic C. pneumoniae infection and COPD, asthma and lung cancer but there have been difficulties detecting C. pneumoniae in the bronchial tree. Cytospin slides prepared from bronchoalveolar lavage (BAL) fluid from 14 patients with COPD, 10 healthy smokers (S) and 7 non smokers (NS) were analyzed with a fluorescein isothiocyanate labeled monoclonal antibody to C. pneumoniae. Lung tissue from 24 patients with advanced emphysema who had undergone lung volume reduction surgery (LVRS) was examined with immunohistochemistry for C. pneumoniae. Archived serum samples for detection of specific C. pneumoniae antibodies by microimmunofluorescence were available for 30 of the BAL subjects and 11 of LVRS patients. C. pneumoniae elementary body like structures were found in 29% of cytospin specimens from COPD patients, 14% of NS and 10% of HS. C. pneumoniae was detected in lung tissue in 8%. COPD patients had higher titres of IgG and IgA than NS and S. There was no association between occurrence of C. pneumoniae in BAL fluid and antibody titres. In conclusion, the assays used for detection of C. pneumoniae in lung tissue are feasible, and could be adapted in adequately powered studies to further confirm an association between C. pneumoniae infection and COPD.

Published
2007

44. Effects of smoking, gender and occupational exposure on the risk of severe pulmonary fibrosis: a population-based case-control study.

Author

Ekström, Magnus, Gustafson, Torbjörn, Boman, Kurt, Nilsson, Kenneth, Tornling, Göran, Murgia, Nicola, Torén, Kjell, Ekström, Magnus, Gustafson, Torbjörn, Boman, Kurt, Nilsson, Kenneth, Tornling, Göran, Murgia, Nicola, and Torén, Kjell

Abstract

To estimate the effects of smoking, gender and occupational exposure on the risk of developing severe pulmonary fibrosis (PF), including dose-response and interaction effects.

Published
2014

49. Occupational exposure and severe pulmonary fibrosis

Author

Gustafson, Torbjörn, Dahlman-Höglund, Anna, Nilsson, Kenneth, Ström, Kerstin, Tornling, Göran, Torén, Kjell, Gustafson, Torbjörn, Dahlman-Höglund, Anna, Nilsson, Kenneth, Ström, Kerstin, Tornling, Göran, and Torén, Kjell

Abstract

BackgroundExternal agents, especially metal and wood dust, are believed to be risk factors for development of idiopathic pulmonary fibrosis (IPF). The aim of this case–control study was to investigate which occupational exposure types are associated with development of severe pulmonary fibrosis (PF), and especially IPF.MethodsAn extensive postal questionnaire including 30 specific items regarding occupational exposure was completed by 181 patients with severe PF and respiratory failure reported to the Swedish Oxygen Register, among whom 140 were judged as having IPF. The questionnaire was also completed by 757 control subjects. We stratified data for age, sex and smoking and calculated odds ratios (ORs).ResultsWe found increased risk for IPF in men with exposure to birch dust (OR 2.7, 95% confidence interval (95% CI) 1.30–5.65) and hardwood dust (OR 2.7, 95% CI 1.14–6.52). Men also had slightly increased ORs associated with birds. We did not find any increased risk in association with metal dust exposure.ConclusionExposure for birch and hardwood dust may contribute to the risk for IPF in men.

Published
2007
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