Observational Study of Obstructive Lung Disease (NOVELTY)
Study Details
Study Description
Brief Summary
The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The NOVELTY study is a multi-country, multicentre, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.
It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.
Exposure(s):
The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).
Sample Size Estimations:
The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.
Statistical Analysis:
After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.
Patients' changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.
To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.
Multivariable models will be used to assess the following: the occurrence of exacerbations and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO) and disease control with impact on daily activity and quality of life, and the relationship between healthcare resource use overall and related to respiratory diseases with disease severity, clinical outcomes, disease type, etc.
Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on biomarkers and/or clinical parameters that are associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Chronic airways disease Patients with suspected or primary diagnosis of asthma or COPD |
Procedure: Blood draw
Biomarkers analyses
Procedure: Urine
Biomarker analyses
Procedure: Lung function measurements
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
Procedure: Fractional Exhaled Nitric Oxide (FENO)
Measures level of exhaled nitric oxide.
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Outcome Measures
Primary Outcome Measures
- Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L]) [Change from baseline FEV1 at Year 1, 2 and 3]
Lung function test
- Spirometry - change in Forced Vital Capacity (FVC) (L) [Change from baseline FVC at Year 1, 2 and 3]
Lung function test
- Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s]) [Change from baseline PEF at Year 1, 2 and 3]
Lung function test
- Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s) [Change from baseline FEF25-75% at Year 1, 2 and 3]
Lung function test
- Spirometry - change in Inspiratory Capacity (IC) (L) [Change from baseline IC at Year 1, 2 and 3]
Lung function test
- Post-bronchodilator spirometry - FEV1 (L) [Baseline]
Bronchodilator reversibility test
- Post-bronchodilator spirometry - FVC (L) [Baseline]
Bronchodilator reversibility test
- Post-bronchodilator spirometry - PEF (L/s) [Baseline]
Bronchodilator reversibility test
- Post-bronchodilator spirometry - FEF25-75% (L/s) [Baseline]
Bronchodilator reversibility test
- Post-bronchodilator spirometry - IC (L) [Baseline]
Bronchodilator reversibility test
- Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb]) [Baseline]
Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
- Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT) [Change from baseline CAAT scores at Year 1, 2, and 3]
Patient reported outcome questionnaire
- Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale [Baseline]
Patient reported outcome questionnaire
- Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ) [Change from baseline RSQ scores at Year 1, 2 and 3]
Patient reported outcome questionnaire
- Change in symptoms/symptom control assessed by the Asthma Control Test (ACT) [Change from baseline ACT scores at Year 1, 2 and 3]
Patient reported outcome questionnaire
- COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD [Baseline]
Patient reported outcome questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
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Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
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Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
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Enrolment from an active clinical practice
Exclusion Criteria:
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Patients who participated in any respiratory interventional trial during the 12 months prior to enrolment or at enrolment
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Patients who, in the opinion of the physician, are unlikely to complete 3 years of follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity
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Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another respiratory disease such as bronchiectasis or interstitial lung disease together with asthma or COPD will be accepted)
In addition, the following are considered criteria for exclusion from the exploratory genetic research (donation of blood for DNA and RNA analysis)
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Previous allogeneic bone marrow transplant
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Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Loma Linda | California | United States | 92357 |
2 | Research Site | Long Beach | California | United States | 90822 |
3 | Research Site | Roseville | California | United States | 95819-3957 |
4 | Research Site | Aurora | Colorado | United States | 80045 |
5 | Research Site | Colorado Springs | Colorado | United States | 80907 |
6 | Research Site | Clearwater | Florida | United States | 33765 |
7 | Research Site | Gainesville | Florida | United States | 32608-1197 |
8 | Research Site | Miami | Florida | United States | 33032 |
9 | Research Site | Miami | Florida | United States | 33125 |
10 | Research Site | Plantation | Florida | United States | 33317 |
11 | Research Site | Chicago | Illinois | United States | 60612 |
12 | Research Site | Springfield | Illinois | United States | 62704 |
13 | Research Site | Hutchinson | Kansas | United States | 67502 |
14 | Research Site | Shreveport | Louisiana | United States | 71106 |
15 | Research Site | Fall River | Massachusetts | United States | 2720 |
16 | Research Site | Ann Arbor | Michigan | United States | 48106 |
17 | Research Site | Buckley | Michigan | United States | 49620 |
18 | Research Site | Hamtramck | Michigan | United States | 48212 |
19 | Research Site | Lincoln | Nebraska | United States | 68505 |
20 | Research Site | Atco | New Jersey | United States | 8004 |
21 | Research Site | Highland Park | New Jersey | United States | 8904 |
22 | Research Site | Albuquerque | New Mexico | United States | 87109 |
23 | Research Site | Bronx | New York | United States | 10459 |
24 | Research Site | Bronx | New York | United States | 10461 |
25 | Research Site | Bronx | New York | United States | 10465 |
26 | Research Site | New York | New York | United States | 10001 |
27 | Research Site | New York | New York | United States | 10016 |
28 | Research Site | Rockville Centre | New York | United States | 11570 |
29 | Research Site | Fargo | North Dakota | United States | 58104 |
30 | Research Site | Cincinnati | Ohio | United States | 45212 |
31 | Research Site | Dayton | Ohio | United States | 45417 |
32 | Research Site | Wooster | Ohio | United States | 44691 |
33 | Research Site | Clackamas | Oregon | United States | 97015 |
34 | Research Site | DuBois | Pennsylvania | United States | 15801 |
35 | Research Site | Providence | Rhode Island | United States | 2941 |
36 | Research Site | Austin | Texas | United States | 78731 |
37 | Research Site | Houston | Texas | United States | 77043 |
38 | Research Site | Live Oak | Texas | United States | 78233 |
39 | Research Site | San Antonio | Texas | United States | 78023 |
40 | Research Site | Richmond | Virginia | United States | 23219 |
41 | Research Site | Charleston | Washington | United States | 25304 |
42 | Research Site | Buenos Aires | Argentina | ||
43 | Research Site | Caba | Argentina | ||
44 | Research Site | Concepcion del Uruguay | Argentina | ||
45 | Research Site | Cordoba | Argentina | ||
46 | Research Site | Mendoza | Argentina | ||
47 | Research Site | Monte Grande | Argentina | ||
48 | Research Site | Pilar | Argentina | ||
49 | Research Site | San Miguel de Tucuman | Argentina | ||
50 | Research Site | San Salvador | Argentina | ||
51 | Research Site | Tandil | Argentina | ||
52 | Research Site | Bedford Park | Australia | ||
53 | Research Site | Blacktown | Australia | ||
54 | Research Site | Cairns | Australia | ||
55 | Research Site | Camperdown | Australia | ||
56 | Research Site | Coffs Harbour | Australia | ||
57 | Research Site | Concord | Australia | ||
58 | Research Site | Frankston | Australia | ||
59 | Research Site | Happy Valley | Australia | ||
60 | Research Site | Kanwal | Australia | ||
61 | Research Site | Kingswood | Australia | ||
62 | Research Site | Kippa Ring | Australia | ||
63 | Research Site | Liverpool BC | Australia | ||
64 | Research Site | Macquarie Park | Australia | ||
65 | Research Site | Miranda | Australia | ||
66 | Research Site | Nedlands | Australia | ||
67 | Research Site | New Lambton | Australia | ||
68 | Research Site | Parkville | Australia | ||
69 | Research Site | Randwick NSW | Australia | ||
70 | Research Site | Redcliffe | Australia | ||
71 | Research Site | South Brisbane | Australia | ||
72 | Research Site | Spearwood | Australia | ||
73 | Research Site | Wamberal | Australia | ||
74 | Research Site | West Gosford | Australia | ||
75 | Research Site | Woodville | Australia | ||
76 | Research Site | Blumenau | Brazil | ||
77 | Research Site | Goiania | Brazil | ||
78 | Research Site | Rio de Janeiro | Brazil | ||
79 | Research Site | Sao Paulo | Brazil | ||
80 | Research Site | Uberlandia | Brazil | ||
81 | Research Site | Edmonton | Alberta | Canada | |
82 | Research Site | London | British Columbia | Canada | |
83 | Research Site | Vancouver | British Columbia | Canada | |
84 | Research Site | Moncton | New Brunswick | Canada | |
85 | Research Site | Burlington | Ontario | Canada | |
86 | Research Site | Downsview, Ontario | Ontario | Canada | |
87 | Research Site | Fort Erie | Ontario | Canada | |
88 | Research Site | Hamilton | Ontario | Canada | |
89 | Research Site | London | Ontario | Canada | |
90 | Research Site | Mississauga | Ontario | Canada | |
91 | Research Site | North York | Ontario | Canada | |
92 | Research Site | Oshawa | Ontario | Canada | |
93 | Research Site | Thorold | Ontario | Canada | |
94 | Research Site | Windsor | Ontario | Canada | |
95 | Research Site | St-Charles-Borromee | Quebec | Canada | |
96 | Research Site | Quebec | Canada | ||
97 | Research Site | Baotou | China | ||
98 | Research Site | Beijing | China | ||
99 | Research Site | Changchun | China | ||
100 | Research Site | Changsha Shi | China | ||
101 | Research Site | Chengdu | China | ||
102 | Research Site | Dongguan | China | ||
103 | Research Site | Guangzhou | China | ||
104 | Research Site | Hangzhou | China | ||
105 | Research Site | Huhehaote Shi | China | ||
106 | Research Site | Ji Nan | China | ||
107 | Research Site | Jinhua | China | ||
108 | Research Site | Nanchang | China | ||
109 | Research Site | Nanjing | China | ||
110 | Research Site | Shantou | China | ||
111 | Research Site | Shenzhen | China | ||
112 | Research Site | Shiyan | China | ||
113 | Research Site | Suzhou Shi | China | ||
114 | Research Site | Wei Fang | China | ||
115 | Research Site | Wuhan | China | ||
116 | Research Site | Xi'an | China | ||
117 | Research Site | Yangzhou | China | ||
118 | Research Site | Yanji | China | ||
119 | Research Site | Zhengzhou | China | ||
120 | Research Site | Antioquia | Colombia | ||
121 | Research Site | Bogota | Colombia | ||
122 | Research Site | Bucaramanga | Colombia | ||
123 | Research Site | Manizales | Colombia | ||
124 | Research Site | Villavicencio | Colombia | ||
125 | Research Site | Zipaquira | Colombia | ||
126 | Research Site | Aalborg | Denmark | ||
127 | Research Site | Aarhus | Denmark | ||
128 | Research Site | Vejle | Denmark | ||
129 | Research Site | Viby J | Denmark | ||
130 | Research Site | Aix en Provence | France | ||
131 | Research Site | Bersee | France | ||
132 | Research Site | Besancon Cedex | France | ||
133 | Research Site | Biarritz | France | ||
134 | Research Site | Brest | France | ||
135 | Research Site | Caen | France | ||
136 | Research Site | Clermont Ferrand Cedex 1 | France | ||
137 | Research Site | Creteil | France | ||
138 | Research Site | Dijon | France | ||
139 | Research Site | Le Mans | France | ||
140 | Research Site | Lille Cedex | France | ||
141 | Research Site | Limoges | France | ||
142 | Research Site | Lyon | France | ||
143 | Research Site | Montivilliers | France | ||
144 | Research Site | Montpellier | France | ||
145 | Research Site | Mulhouse | France | ||
146 | Research Site | Nancy | France | ||
147 | Research Site | Orleans cedex 2 | France | ||
148 | Research Site | Paris | France | ||
149 | Research Site | Pau | France | ||
150 | Research Site | Perpignan | France | ||
151 | Research Site | Pessac | France | ||
152 | Research Site | Rouen | France | ||
153 | Research Site | Strasbourg | France | ||
154 | Research Site | Tarbes | France | ||
155 | Research Site | Villefranche-sur-Saone | France | ||
156 | Research Site | Augsburg | Germany | ||
157 | Research Site | Berlin | Germany | ||
158 | Research Site | Bruchsal | Germany | ||
159 | Research Site | Dillingen | Germany | ||
160 | Research Site | Dresden | Germany | ||
161 | Research Site | Halberstadt | Germany | ||
162 | Research Site | Hamburg | Germany | ||
163 | Research Site | Heidelberg | Germany | ||
164 | Research Site | Homburg | Germany | ||
165 | Research Site | Ibbenbueren | Germany | ||
166 | Research Site | Leipzig | Germany | ||
167 | Research Site | Luebeck | Germany | ||
168 | Research Site | Marburg | Germany | ||
169 | Research Site | Munich | Germany | ||
170 | Research Site | Peine | Germany | ||
171 | Research Site | Ratingen | Germany | ||
172 | Research Site | Reinfeld | Germany | ||
173 | Research Site | Rudersdorf | Germany | ||
174 | Research Site | Schleswig | Germany | ||
175 | Research Site | Ancona | Italy | ||
176 | Research Site | Battipaglia | Italy | ||
177 | Research Site | Biancavilla | Italy | ||
178 | Research Site | Catania | Italy | ||
179 | Research Site | Chieti | Italy | ||
180 | Research Site | Ferrara | Italy | ||
181 | Research Site | Firenze | Italy | ||
182 | Research Site | Foggia | Italy | ||
183 | Research Site | Genova | Italy | ||
184 | Research Site | Livorno | Italy | ||
185 | Research Site | Mantova | Italy | ||
186 | Research Site | Messina | Italy | ||
187 | Research Site | Modena | Italy | ||
188 | Research Site | Montescano | Italy | ||
189 | Research Site | Monza | Italy | ||
190 | Research Site | Napoli | Italy | ||
191 | Research Site | Orbassano | Italy | ||
192 | Research Site | Palermo | Italy | ||
193 | Research Site | Pordenone | Italy | ||
194 | Research Site | Roma | Italy | ||
195 | Research Site | Sassari | Italy | ||
196 | Research Site | Fukuoka-shi | Japan | ||
197 | Research Site | Fukuoka | Japan | ||
198 | Research Site | Fukushima | Japan | ||
199 | Research Site | Higashiibaraki | Japan | ||
200 | Research Site | Ishinomaki | Japan | ||
201 | Research Site | Itami | Japan | ||
202 | Research Site | Kanazawa | Japan | ||
203 | Research Site | Kishiwada | Japan | ||
204 | Research Site | Kitakyu | Japan | ||
205 | Research Site | Kiyose | Japan | ||
206 | Research Site | Kobe | Japan | ||
207 | Research Site | Kurume-Shi | Japan | ||
208 | Research Site | Matsue | Japan | ||
209 | Research Site | Mibu-Machi | Japan | ||
210 | Research Site | Nagoya | Japan | ||
211 | Research Site | Nakano-ku | Japan | ||
212 | Research Site | Omuta-shi | Japan | ||
213 | Research Site | Shizuoka-shi | Japan | ||
214 | Research Site | Shizuoka | Japan | ||
215 | Research Site | Tokyo | Japan | ||
216 | Research Site | Toyama | Japan | ||
217 | Research Site | Yamagata | Japan | ||
218 | Research Site | Yokohama | Japan | ||
219 | Research Site | Anyang-si | Korea, Republic of | ||
220 | Research Site | Chuncheon-si | Korea, Republic of | ||
221 | Research Site | Gwangju | Korea, Republic of | ||
222 | Research Site | Gyeonggi-do | Korea, Republic of | ||
223 | Research Site | Incheon | Korea, Republic of | ||
224 | Research Site | Jeonju-si | Korea, Republic of | ||
225 | Research Site | Nam-gu | Korea, Republic of | ||
226 | Research Site | Seoul | Korea, Republic of | ||
227 | Research Site | Suwon-si | Korea, Republic of | ||
228 | Research Site | Wonmi-gu, Bucheon-si | Korea, Republic of | ||
229 | Research Site | Guadalajara | Mexico | ||
230 | Research Site | Mexico | Mexico | ||
231 | Research Site | Monterrey | Mexico | ||
232 | Research Site | Pachuca De Soto | Mexico | ||
233 | Research Site | Puebla | Mexico | ||
234 | Research Site | Villahermosa | Mexico | ||
235 | Research Site | Alkmaar | Netherlands | ||
236 | Research Site | Arnhem | Netherlands | ||
237 | Research Site | Breda | Netherlands | ||
238 | Research Site | Enschede | Netherlands | ||
239 | Research Site | Groningen | Netherlands | ||
240 | Research Site | Horn | Netherlands | ||
241 | Research Site | Nieuwegein | Netherlands | ||
242 | Research Site | Nijmegen | Netherlands | ||
243 | Research Site | Rotterdam | Netherlands | ||
244 | Research Site | Veldhoven | Netherlands | ||
245 | Research Site | Zutphen | Netherlands | ||
246 | Research Site | Jassheim | Norway | ||
247 | Research Site | Lorenskog | Norway | ||
248 | Research Site | Oslo | Norway | ||
249 | Research Site | Tananger | Norway | ||
250 | Research Site | Trollasen | Norway | ||
251 | Research Site | Trondheim | Norway | ||
252 | Research Site | Alcala de Henares | Spain | ||
253 | Research Site | Alcazar de San Juan | Spain | ||
254 | Research Site | Badajoz | Spain | ||
255 | Research Site | Badalona | Spain | ||
256 | Research Site | Baracaldo, Bizcaia | Spain | ||
257 | Research Site | Barcelona | Spain | ||
258 | Research Site | Burgos | Spain | ||
259 | Research Site | Cartagena | Spain | ||
260 | Research Site | Centelles | Spain | ||
261 | Research Site | Ceuta | Spain | ||
262 | Research Site | Granada | Spain | ||
263 | Research Site | Lugo | Spain | ||
264 | Research Site | Madrid | Spain | ||
265 | Research Site | Malaga | Spain | ||
266 | Research Site | Mostoles | Spain | ||
267 | Research Site | Murcia | Spain | ||
268 | Research Site | Oviedo | Spain | ||
269 | Research Site | Palma de Mallorca | Spain | ||
270 | Research Site | Palmones | Spain | ||
271 | Research Site | Pamplona | Spain | ||
272 | Research Site | Pozuelo de Alarcon | Spain | ||
273 | Research Site | Sta. Cruz de Tenerife | Spain | ||
274 | Research Site | Torrelaguna | Spain | ||
275 | Research Site | Valladolid | Spain | ||
276 | Research Site | Vigo | Spain | ||
277 | Research Site | Zaragoza | Spain | ||
278 | Research Site | Frolunda | Sweden | ||
279 | Research Site | Lund | Sweden | ||
280 | Research Site | Stockholm | Sweden | ||
281 | Research Site | Uppsala | Sweden | ||
282 | Research Site | Varnamo | Sweden | ||
283 | Research Site | Atherstone | United Kingdom | ||
284 | Research Site | Belfast | United Kingdom | ||
285 | Research Site | Birmingham | United Kingdom | ||
286 | Research Site | Chelmsford | United Kingdom | ||
287 | Research Site | Hull | United Kingdom | ||
288 | Research Site | Liverpool | United Kingdom | ||
289 | Research Site | London | United Kingdom | ||
290 | Research Site | Macclesfield | United Kingdom | ||
291 | Research Site | Manchester | United Kingdom | ||
292 | Research Site | Middlesbrough | United Kingdom | ||
293 | Research Site | Newport | United Kingdom | ||
294 | Research Site | Nottingham | United Kingdom | ||
295 | Research Site | Pickering | United Kingdom | ||
296 | Research Site | South Shields | United Kingdom | ||
297 | Research Site | Southampton | United Kingdom | ||
298 | Research Site | Swansea | United Kingdom | ||
299 | Research Site | Thornton Cleveleys | United Kingdom | ||
300 | Research Site | Watford | United Kingdom | ||
301 | Research Site | Wigginton | United Kingdom | ||
302 | Research Site | Wishaw | United Kingdom | ||
303 | Research Site | York | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
- Parexel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D2287R00103