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2. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials

Author

Fabbri, Leonardo M., Calverley, Peter M. A., Jose Luis Izquierdo Alonso, Bundschuh, Daniela S., Manja, Brose, Martinez, Fernando J., Rabe, Kf M., Study Groups Abdulla, M., Abdullah, I., Adler, M., Aguilaniu, Albert, I., Almonacid, C., Altés, A., Amaducci, S., Angrill, J., Antonana, J. M., Artner, H., Balint, B., Bantje, T. A., Barbe, F., Bateman, E., Bauchnect, E., Belda, J., Bernabeu, L., Bettendorf, A., Blagden, M., Blanquer, R., Blecher, L., Bonnaud, F., Bourbeau, J., Boyer, G. R., Brotons, C., Bruning, A. H., Bucca, C., Burns, G. E., Von Der Heydt, B. B., Caldwell, Canonica, G. W., Carter, J., Chan, V., Chapman, K. R., Chapman, G., Cheung, D., Chiner, E., Chopra, A., Clini, E., Coulet, P., Craig, B., Croonenborghs, L., Czompó, M., Dal Negro, R. W., Dapper, T., De Graaff, C. S., Ramos Pde, L., De Munck, D. R., Decramer, M., Delobbe, A., Denier, W., De Teresa, L., Dhar, A., Di Maria, G., Dupouy, J., Duschek, G., Echave, J., Esteban, C., Farmer, I. S., Flemale, A., Fletcher, P., Foden, Fouquert, L., Franz, K. H., Frognier, Gagnon, M., Garcia, Mdel M., Garelli, G., Gehling, U., Ginko, T., Glekin, B., Gooding, T., Graham, A., Greillier, P., Greses, J. V., Grillenberger, J., Gross, B., Grygier, H., Gyori, Z., Harper, Henein, S., Heredia, J. L., Hernandez, P., Hoefer, M., Hoffstein, V., Holgate, K., Holler, W., Holub, G., Homik, L., Houle, P. A., Hutter, C., Hyvernat, P., Irusen, E. M., Jackson, A., Janisty, W., Jasnot, J. Y., Joubert, J., Juhasz, G., Jullian, H., Kafe, H., Kelly, P., Kidney, J., Killian, K., Kinch, H., Kirsten, D. L., Kleinecke Pohl, U., Korlipara, K., Krige, L. P., Kroker, A., Kuipers, A. F., Labrecque, M., Larivee, P., Laskowitz, C., Le Merre, C., Lemoigne, F., Ludwig Sengpiel, A., Luengo, M., Luton, R., Macnee, W., Ali, S. M., Maltais, F., Mansur, A., Marciniuk, D., Marin, A., Martin, P., Martinot, J. B., Mazza, F., Bride, M. C., Mcdonald, B., Mckinnon, C., Mclvor, A., Mcnally, D., Mengeot, P. M., Messner, J., Moder, G., Mooney, P., Moretti, A. M., Muller, D., Murio, C., Nardini, S., Nel, A., Ochoa, Saracho Jo, D. E., Paggiaro, P., Paradis, B., Patrick, J., Peche, R., Pellicer, C., Perez, T., Perez, E., De Llano, L. A., Philteos, G., Pieters, W. R., Pigearias, B., Pohl, W., Popovic, R., Prins, M., Querfurt, H., Rajkay, K., Ras, G., Road, J., Roig, J., Roldaan, A. C., Rolke, M., Rozen, D., Sanchez Toril, F., Savani, N., Savary, L., Schiavina, M., Schiesbühl, H., Schreurs, A. J., Schröder Babo, W., Schurmann, W., Seiz, V., Sevette, C., Sharma, R., Shum, C., Damsté, H. E., Smithers, A., Soler, J. J., Steffen, H., Steinhauser, U., Sweilem, M., Tellier, G., Terol, B., Terzano, Claudio, Timar, M., Toma, G., Monserrat, P. T., Trauth, H. A., Valyon, E., Brande Van Den, Van Noord, J. A., Vaquer, J. V., Hernandez Hector, H. V., Vereecken, G., Verkindre, C., Vigh, M., Viljoen, J. J., Vincken, W., Vinkler, I., Visser, S., Volgmann, L., Vorderstrasse, W., Voves, R., Vrancken, F., Weber, H. H., Wielders, P. L., Willoughby, P., Wurtz, J., Yang, W., Zabaleta, M., Zachgo, W., Zanini, A., Zeiner, M., Michael, H., Janistyn, W., Abdulla, R., Terzano, C., Fabbri, L., Barbaro, M. P., Izquierdo, J. L., Ramos, Pde L., and Harper, Ochoa

Subjects
Chronic bronchitis, medicine.drug_class, glucocorticosteroids, Placebo, exacerbations, Bronchodilator, medicine, COPD, humans, Roflumilast, Intention-to-treat analysis, business.industry, Body weight, chronic bronchitis, emphysema, inflammation, lung function, phosphodiesterase 4 inhibitor, PDE4, General Medicine, Tiotropium bromide, medicine.disease, respiratory tract diseases, Anesthesia, Salmeterol, business, medicine.drug
Abstract

Summary Background Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment. The efficacy and safety of the phosphodiesterase-4 inhibitor roflumilast have been investigated in studies of patients with moderate-to-severe COPD, but not in those concomitantly treated with longacting inhaled bronchodilators. The effect of roflumilast on lung function in patients with COPD that is moderate to severe who are already being treated with salmeterol or tiotropium was investigated. Methods In two double-blind, multicentre studies done in an outpatient setting, after a 4-week run-in, patients older than 40 years with moderate-to-severe COPD were randomly assigned to oral roflumilast 500 μg or placebo once a day for 24 weeks, in addition to salmeterol (M2-127 study) or tiotropium (M2-128 study). The primary endpoint was change in prebronchodilator forced expiratory volume in 1 s (FEV 1 ). Analysis was by intention to treat. The studies are registered with ClinicalTrials.gov, number NCT00313209 for M2-127, and NCT00424268 for M2-128. Findings In the salmeterol plus roflumilast trial, 466 patients were assigned to and treated with roflumilast and 467 with placebo; in the tiotropium plus roflumilast trial, 371 patients were assigned to and treated with roflumilast and 372 with placebo. Compared with placebo, roflumilast consistently improved mean prebronchodilator FEV 1 by 49 mL (p 1 was noted in both groups. Furthermore, roflumilast had beneficial effects on other lung function measurements and on selected patient-reported outcomes in both groups. Nausea, diarrhoea, weight loss, and, to a lesser extent, headache were more frequent in patients in the roflumilast groups. These adverse events were associated with increased patient withdrawal. Interpretation Roflumilast improves lung function in patients with COPD treated with salmeterol or tiotropium, and could become an important treatment for these patients. Funding Nycomed.

Published
2009
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4. Contents, Vol. 53, 1988

Author

Neil Schachter, Robert H. Israel, Michael C. Kallay, Dario Olivieri, A. Flemale, Amund Gulsvik, A. Foresi, Robert H. Poe, Stavros H. Constantopoulos, Andreas Myking, I. Perlot, Theodore J. Witek, B. Guillot, Gregory Elliott, Giuseppe Maria Corbo, J.J. Pocidalo, A. Cuomo, H.M. Moutsopoulos, P. Aubas, Salvatore Valente, A. Lurie, G. Gurrieri, D. Theven, Elsa Skaarland, F.B. Michel, Donald W. Greenblatt, A. Chetta, James M. Kohan, M.B. Brun-Pascaud, Edward Stark, A.A. Drosos, P. Chanez, Odd Mørkve, Susan Rathbun, Ph. Gris, J.-P. Delmez, Thomas V. Colby, Robert O. Crapo, Tracy Hill, C. Mion, G. Garavaldi, J.-P. Dierckx, Ph. Godard, Lodve Stangeland, G. Mourad, M. Fay, and Andrew P. Andonopoulos

Subjects
Pulmonary and Respiratory Medicine, Traditional medicine, business.industry, Medicine, business
Published
1988
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5. Pulmonary hypertension associated with portal thrombosis

Author

A, Flemale, J P, Sabot, M, Popijn, M, Procureur, G, Urbain, J P, Dierckx, and J P, Delmez

Subjects
Adult, Portal Vein, Hypertension, Pulmonary, Hypertension, Portal, Humans, Thrombosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
Abstract

Pulmonary hypertension accompanying portal hypertension is a rare cause of plexogenic pulmonary arteriopathy, which etiopathogenesis is still unknown. The case report presented is that of a young man who underwent surgery at age 8 for ruptured esophageal varices associated with portal thrombosis, and who later developed pulmonary hypertension which led to death at age 21. Hepatic filtration shunt and similarity of this syndrome to pulmonary hypertension subsequent to ingestion of the appetite depressant Aminorex suggest the hypothesis that pressor substances, not detoxified by the liver, are released into the pulmonary circulation.

Published
1985

6. [A new case of hypersensitivity pneumopathy caused by salazopyrine?]

Author

K, Laurent, M, De Jonghe, A, Flemale, P, Kimbimbi, P, Defrance, and C, Gillard

Subjects
Sulfasalazine, Drug Combinations, Glucosamine, Humans, Colitis, Ulcerative, Female, Middle Aged, Alveolitis, Extrinsic Allergic
Abstract

On the basis of a new case of Salazopyrine hypersensitivity pneumonitis, the authors describe the value of bronchoalveolar lavage and of the lymphoblast transformation test. They also describe the difficulties in making the diagnosis of such pathology and review the various possible differential diagnoses in their patient.

Published
1985

7. Comparison of central venous, oesophageal and mouth occlusion pressure with water-filled catheters for estimating pleural pressure changes in healthy adults

Author

A, Flemale, C, Gillard, and J P, Dierckx

Subjects
Adult, Male, Catheterization, Central Venous, Mouth, Esophagus, Central Venous Pressure, Posture, Humans, Pleura, Female, Catheterization
Abstract

The validity of the central venous and water-filled oesophageal catheter technique as a measure of pleural pressure changes was tested in ten healthy subjects in different body positions during inspiratory efforts with occluded airways, by comparing the simultaneous changes in mouth pressure (delta Pm) taken to represent pleural pressure changes, in central venous pressure (delta Pcv) and in oesophageal pressure (delta Poes). delta Pcv/delta Pm values were close to unity in the sitting and left lateral positions, whereas in the supine and right lateral position, substantial deviations from unity were found in some instances. delta Poes/delta Pm values were close to unity in all positions, except some rare instances. No appreciable phase difference between delta Pm/delta Poes and delta Pm/delta Pcv was found when the amplitude ratios were close to unity. We conclude that valid measurements of pleural pressure changes can be obtained in most instances with the central venous and the water-filled oesophageal catheter system according to the occlusion test procedure.

Published
1988

8. Coxsackie B3 virus: an unusual cause of unilateral mediastinal nodal enlargement

Author

J.-P. Delmez, A. Flemale, J.-P. Dierckx, Ph. Gris, and I. Perlot

Subjects
Pulmonary and Respiratory Medicine, Male, Pathology, medicine.medical_specialty, Lung, business.industry, Respiratory disease, Mediastinum, Coxsackievirus Infections, medicine.disease, medicine.disease_cause, Virus, Enterovirus B, Human, medicine.anatomical_structure, Effusion, medicine, Paratracheal, Enterovirus, Humans, Lymph, Lymph Nodes, business, Lymphatic Diseases, Aged
Abstract

We report on a patient with febrile illness, right unilateral paratracheal widening, pulmonary infiltrates, pleural effusions, exanthema and diarrhea. The right paratracheal widening was due to lymph node enlargement confirmed by CT scan. Symptoms disappeared subsequently without specific treatment. On the basis of serological tests, we are able to diagnose a coxsackie B3 virus infection. No previous case report of unilateral mediastinal nodal enlargement contemporary to a coxsackie B3 virus infection was found in our review of the literature.

Published
1988

9. Subject Index, Vol. 53, 1988

Author

Robert H. Poe, D. Theven, I. Perlot, Thomas V. Colby, Andrew P. Andonopoulos, Dario Olivieri, Lodve Stangeland, Gregory Elliott, Ph. Godard, M. Fay, G. Mourad, A. Flemale, H.M. Moutsopoulos, Amund Gulsvik, A. Foresi, J.-P. Delmez, M.B. Brun-Pascaud, Tracy Hill, Edward Stark, C. Mion, Neil Schachter, Salvatore Valente, Theodore J. Witek, F.B. Michel, Susan Rathbun, Robert H. Israel, Ph. Gris, Donald W. Greenblatt, Elsa Skaarland, A. Cuomo, A.A. Drosos, Stavros H. Constantopoulos, P. Aubas, Andreas Myking, A. Lurie, G. Gurrieri, Michael C. Kallay, A. Chetta, B. Guillot, Giuseppe Maria Corbo, J.J. Pocidalo, G. Garavaldi, J.-P. Dierckx, James M. Kohan, Robert O. Crapo, P. Chanez, and Odd Mørkve

Subjects
Pulmonary and Respiratory Medicine, Index (economics), business.industry, Statistics, Medicine, Subject (documents), business
Published
1988
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10. Pulmonary hypertension associated with portal thrombosis.

Author

Flemale A, Sabot JP, Popijn M, Procureur M, Urbain G, Dierckx JP, and Delmez JP

Subjects
Adult, Esophageal and Gastric Varices pathology, Gastrointestinal Hemorrhage pathology, Humans, Hypertension, Portal complications, Hypertension, Portal physiopathology, Hypertension, Pulmonary etiology, Thrombosis complications, Hypertension, Pulmonary physiopathology, Portal Vein, Thrombosis physiopathology
Abstract

Pulmonary hypertension accompanying portal hypertension is a rare cause of plexogenic pulmonary arteriopathy, which etiopathogenesis is still unknown. The case report presented is that of a young man who underwent surgery at age 8 for ruptured esophageal varices associated with portal thrombosis, and who later developed pulmonary hypertension which led to death at age 21. Hepatic filtration shunt and similarity of this syndrome to pulmonary hypertension subsequent to ingestion of the appetite depressant Aminorex suggest the hypothesis that pressor substances, not detoxified by the liver, are released into the pulmonary circulation.

Published
1985

11. Comparison of central venous, oesophageal and mouth occlusion pressure with water-filled catheters for estimating pleural pressure changes in healthy adults.

Author

Flemale A, Gillard C, and Dierckx JP

Subjects
Adult, Female, Humans, Male, Posture, Catheterization, Catheterization, Central Venous, Central Venous Pressure, Esophagus physiology, Mouth physiology, Pleura physiology
Abstract

The validity of the central venous and water-filled oesophageal catheter technique as a measure of pleural pressure changes was tested in ten healthy subjects in different body positions during inspiratory efforts with occluded airways, by comparing the simultaneous changes in mouth pressure (delta Pm) taken to represent pleural pressure changes, in central venous pressure (delta Pcv) and in oesophageal pressure (delta Poes). delta Pcv/delta Pm values were close to unity in the sitting and left lateral positions, whereas in the supine and right lateral position, substantial deviations from unity were found in some instances. delta Poes/delta Pm values were close to unity in all positions, except some rare instances. No appreciable phase difference between delta Pm/delta Poes and delta Pm/delta Pcv was found when the amplitude ratios were close to unity. We conclude that valid measurements of pleural pressure changes can be obtained in most instances with the central venous and the water-filled oesophageal catheter system according to the occlusion test procedure.

Published
1988

12. [A new case of hypersensitivity pneumopathy caused by salazopyrine?].

Author

Laurent K, De Jonghe M, Flemale A, Kimbimbi P, Defrance P, and Gillard C

Subjects
Alveolitis, Extrinsic Allergic diagnosis, Colitis, Ulcerative drug therapy, Drug Combinations adverse effects, Female, Glucosamine adverse effects, Humans, Middle Aged, Alveolitis, Extrinsic Allergic chemically induced, Glucosamine analogs & derivatives, Sulfasalazine adverse effects
Abstract

On the basis of a new case of Salazopyrine hypersensitivity pneumonitis, the authors describe the value of bronchoalveolar lavage and of the lymphoblast transformation test. They also describe the difficulties in making the diagnosis of such pathology and review the various possible differential diagnoses in their patient.

Published
1985

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