NCT02224157

Brief Summary

The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
4,215

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Nov 2014

Typical duration for phase_3 asthma

Geographic Reach
25 countries

340 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 28, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2.7 years

First QC Date

August 19, 2014

Results QC Date

August 16, 2018

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis

    Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation

    up to 52 weeks

  • Annual Severe Asthma Exacerbation Rate - Superiority Analysis

    Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation

    up to 52 weeks

Secondary Outcomes (8)

  • Number of Participants Experiencing at Least One Severe Asthma Exacerbation

    Day 1 up to 52 weeks

  • Average Change From Baseline in Pre-bronchodilator FEV1

    Study weeks 0,17, 34, 52

  • Number of Participants With Study Specific Asthma Related Discontinuation

    Day 1 up to 52 weeks

  • Average Change From Baseline in 'as Needed' Use

    Week 0 up to 52 weeks

  • Change From Baseline in Percent of 'as Needed' Free Days

    Week 0 up to 52 weeks

  • +3 more secondary outcomes

Study Arms (2)

Symbicort "as needed"+placebo Pulmicort bid

EXPERIMENTAL

Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid

Drug: budesonide/formoterol 'as needed' + budesonide placebo bid

Pulmicort bid + terbutaline "as needed"

ACTIVE COMPARATOR

Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'

Drug: budesonode bid + terbutaline 'as needed'

Interventions

Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Symbicort "as needed"+placebo Pulmicort bid

Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment

Pulmicort bid + terbutaline "as needed"

Eligibility Criteria

Age12 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
  • Male or Female, ≥12 years of age
  • Documented diagnosis of asthma for at least 6 months prior to Visit 1
  • Patients who are in need of GINA step 2 treatment
  • Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
  • Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
  • Patients should have reversible airway obstruction
  • To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period

You may not qualify if:

  • Patient has a history of life-threatening asthma including intubation and intensive care unit admission
  • Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
  • Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
  • Current or previous smoker with a smoking history of ≥ 10 pack years
  • Pregnancy, breast-feeding or planned pregnancy during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (340)

Research Site

Sydney, 2010, Australia

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Botucatu, 18618-970, Brazil

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Florianópolis, 88040-970, Brazil

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Goiânia, 74110 030, Brazil

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Porto Alegre, 9002-060, Brazil

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Porto Alegre, 90020-060, Brazil

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Porto Alegre, 90110-270, Brazil

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Porto Alegre, 90610-000, Brazil

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Porto Alegre, 91350-200, Brazil

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Salvador, 41940-455, Brazil

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Santo André, 09080-110, Brazil

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São Paulo, 02189-000, Brazil

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São Paulo, 04020-060, Brazil

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São Paulo, 04101-000, Brazil

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São Paulo, 04266-010, Brazil

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São Paulo, 05403-900, Brazil

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Sorocaba, 18040-425, Brazil

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Blagoevgrad, 2700, Bulgaria

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Pernik, 2300, Bulgaria

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Petrich, 2850, Bulgaria

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Pleven, 5800, Bulgaria

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Razlog, 2760, Bulgaria

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Sliven, 8800, Bulgaria

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Smolyan, 4700, Bulgaria

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Sofia, 1404, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1408, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1612, Bulgaria

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Sofia, 1618, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Varna, 9000, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Vidin, 3700, Bulgaria

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Yambol, 8600, Bulgaria

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Curicó, 3341643, Chile

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Quillota, 2260000, Chile

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Santiago, 404366, Chile

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Santiago, 8207257, Chile

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Santiago, 8320000, Chile

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Talca, 3465584, Chile

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Viña del Mar, 2520000, Chile

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Barranquilla, 80001, Colombia

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Bogotá, 110221, Colombia

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Bogotá, 111211, Colombia

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Bogotá, 111511, Colombia

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Medellín, 5001000, Colombia

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Česká Lípa, 470 01, Czechia

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Kladno, 272 00, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Kutná Hora, 284 01, Czechia

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Liberec, 460 01, Czechia

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Neratovice, 277 01, Czechia

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Ostrava, 709 00, Czechia

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Ostrava, 728 80, Czechia

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Pardubice, 532 03, Czechia

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Pilsen, 301 00, Czechia

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Pilsen, 304 60, Czechia

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Prague, 142 00, Czechia

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Prague, 150 00, Czechia

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Prague, 169 00, Czechia

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Rokycany, 337 22, Czechia

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Rudna U Prahy, 252 19, Czechia

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Tábor, 390 01, Czechia

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Teplice, 415 01, Czechia

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Žatec, 43801, Czechia

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Brii-sous-forges, 91640, France

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Colmar, 68000, France

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Joué-lès-Tours, 37300, France

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Nantes, 44277, France

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Nîmes, 30000, France

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Rezé, 44400, France

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Bad Lippspringe, 33175, Germany

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Berlin, 10119, Germany

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Berlin, 10367, Germany

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Berlin, 10629, Germany

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Berlin, 10787, Germany

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Berlin, 13507, Germany

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Cottbus, 03050, Germany

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Frankfurt am Main, 60389, Germany

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Geesthacht, 21502, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 20354, Germany

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Hanover, D-30173, Germany

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Leipzig, 04103, Germany

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Leipzig, 04207, Germany

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Leipzig, 04357, Germany

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Lübeck, 23552, Germany

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Neu-Isenburg, 63263, Germany

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Oldenburg, 23758, Germany

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Reinfeld, 23858, Germany

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Rüdersdorf, 15562, Germany

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Schleswig, 24837, Germany

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Warendorf, 48231, Germany

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Aszód, 2170, Hungary

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Balassagyarmat, 2660, Hungary

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Berettyóújfalu, 4100, Hungary

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Budapest, 1036, Hungary

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Budapest, 1135, Hungary

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Budapest, 1145, Hungary

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Budapest, 1191, Hungary

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Cegléd, 2700, Hungary

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Érd, 2030, Hungary

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Gödöllő, 2100, Hungary

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Gyula, 5700, Hungary

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Gyula, 5703, Hungary

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Hajdúnánás, 4080, Hungary

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Létavértes, 4281, Hungary

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Makó, 6900, Hungary

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Miskolc, 3529, Hungary

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Mórahalom, 6782, Hungary

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Pécs, 7635, Hungary

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Siófok, 8600, Hungary

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Szeged, H-6722, Hungary

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Szombathely, 9700, Hungary

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Vásárosnamény, 4800, Hungary

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Chihuahua City, 31203, Mexico

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Guadalajara, 44100, Mexico

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Guadalajara, 44670, Mexico

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Mexico City, 6726, Mexico

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Mérida, 97070, Mexico

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México, 06720, Mexico

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San Juan del Río, 76800, Mexico

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Tlanepantla, 54055, Mexico

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Villahermosa, 86035, Mexico

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Zapopan, 45200, Mexico

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Auckland, 0626, New Zealand

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Christchurch, 8024, New Zealand

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Christchurch, 8041, New Zealand

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Christchurch Central, 8011, New Zealand

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Grafton, 1010, New Zealand

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Hamilton West, 3204, New Zealand

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Maroubra, 2035, New Zealand

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New Lambton, 2310, New Zealand

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Newtown, 6242, New Zealand

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Rotorua, 3010, New Zealand

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South Brisbane, 4101, New Zealand

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Tauranga, 3143, New Zealand

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Wellington, 6021, New Zealand

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Chancay, 15131, Peru

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Lima, 15033, Peru

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Lima, LIMA 01, Peru

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Lima, LIMA 21, Peru

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Lima, LIMA 27, Peru

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Lima, LIMA 32, Peru

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Lima Cercado, LIMA 1, Peru

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Miraflores, 15046, Peru

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Santa Beatriz, LIMA 14, Peru

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Lipa City, 4217, Philippines

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Manila, Philippines

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Pasig, 1600, Philippines

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Quezon City, 1109, Philippines

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Quezon City, Philippines

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Bialystok, 15-044, Poland

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Bialystok, 15-430, Poland

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Giżycko, 11-500, Poland

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Kościan, 64-000, Poland

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Krakow, 31-559, Poland

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Lublin, 20-709, Poland

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Mrągowo, 11-700, Poland

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Ostrowiec Świętokrzyski, 27-400, Poland

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Ostrów Wielkopolski, 63-400, Poland

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Pabianice, 95-200, Poland

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Piła, 64-920, Poland

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Poznan, 60-685, Poland

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Poznan, 60-693, Poland

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Proszowice, 32-100, Poland

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Rzeszów, 35-205, Poland

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Warsaw, 02-106, Poland

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Zabrze, 41-800, Poland

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Bragadiru, 077025, Romania

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Brasov, 500051, Romania

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Brasov, 500283, Romania

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Bucharest, 030303, Romania

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Constanța, 900002, Romania

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Constanța, Romania

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Deva, 330061, Romania

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Iași, 700115, Romania

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Piteşti, 110084, Romania

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Chelyabinsk, 454021, Russia

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Gatchina, 188300, Russia

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Ivanovo, 153005, Russia

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Izhevsk, 426035, Russia

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Kazan', 420012, Russia

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Kemerovo, 650000, Russia

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Kemerovo, 650002, Russia

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Kemerovo, 650066, Russia

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Moscow, 109240, Russia

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Moscow, 117630, Russia

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Moscow, 121309, Russia

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Moscow, 123182, Russia

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Moscow, 142160, Russia

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Novosibirsk, 630008, Russia

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Novosibirsk, 630051, Russia

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Omsk, 644043, Russia

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Penza, 440067, Russia

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Perm, 614000, Russia

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Pskov, 180007, Russia

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Saint Petersburg, 191144, Russia

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Saint Petersburg, 193231, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194100, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 196211, Russia

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Saint Petersburg, 196240, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 196657, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197342, Russia

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Saint Petersburg, 198205, Russia

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Saint Petersburg, 198260, Russia

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Saratov, 410012, Russia

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Saratov, 410053, Russia

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Tomsk, 634050, Russia

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Tver', 170642, Russia

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Ufa, 450000, Russia

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Ulyanovsk, 432009, Russia

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Vladikavkaz, 362007, Russia

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Volgograd, 400131, Russia

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Vsevolozhsk, 188640, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620137, Russia

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Dhahran, 131932, Saudi Arabia

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Jeddah, 21499, Saudi Arabia

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Jeddah, 22252, Saudi Arabia

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Riyadh, 12371, Saudi Arabia

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Riyadh, 12713, Saudi Arabia

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Kežmarok, 060 01, Slovakia

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Komárno, 945 01, Slovakia

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Košice, 040 22, Slovakia

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Košice, 04022, Slovakia

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Levice, 934 01, Slovakia

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Liptovský Mikuláš, 031 01, Slovakia

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Lučenec, 984 01, Slovakia

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Nitra, 94901, Slovakia

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Nové Zámky, 94001, Slovakia

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Poprad, 058 01, Slovakia

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Poprad, 05801, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Ružomberok, 034 26, Slovakia

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Skalica, 90901, Slovakia

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Šurany, 94201, Slovakia

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Topoľčany, 95501, Slovakia

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Trebišov, 07701, Slovakia

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Zvolen, 96001, Slovakia

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Žilina, 01008, Slovakia

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Bellville, 7530, South Africa

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Boksburg North, 1460, South Africa

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Cape Town, 7570, South Africa

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Cape Town, 7764, South Africa

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Durban, 4001, South Africa

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Durban, 4037, South Africa

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Durban, 4091, South Africa

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Durban, 4092, South Africa

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Johannesburg, 2001, South Africa

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Johannesburg, 2188, South Africa

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Lenasia, 1829, South Africa

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Mowbray, 7700, South Africa

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Panorama, 7500, South Africa

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Phoenix, 4068, South Africa

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Verulam, 4345, South Africa

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Busan, 49201, South Korea

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Cheongju-si, 28644, South Korea

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Daegu, 42415, South Korea

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Incheon, 405-760, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 03080, South Korea

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Seoul, 03312, South Korea

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Seoul, 04401, South Korea

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Seoul, 05030, South Korea

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Seoul, 05505, South Korea

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Seoul, 06591, South Korea

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Seoul, 135-710, South Korea

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Suwon, 16247, South Korea

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Uijeongbu-si, 11765, South Korea

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Wŏnju, 26426, South Korea

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Alicante, 03004, Spain

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Badalona, 08916, Spain

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Barcelona, 08025, Spain

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Barcelona, 08036, Spain

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Bilbao (Vizcaya), 48013, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Marbella (Málaga), 29603, Spain

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Málaga, 29730, Spain

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Oviedo, 33011, Spain

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Seville, 41013, Spain

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Seville, 41071, Spain

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Terrassa (Barcelona), 08227, Spain

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Valencia, 46017, Spain

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Borås, 506 30, Sweden

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Lund, 222 21, Sweden

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Malmo, 21152, Sweden

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Stockholm, 114 46, Sweden

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Värnamo, 33185, Sweden

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Västra Frölunda, 42144, Sweden

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10600, Thailand

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Bangkok, 10700, Thailand

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Chon Buri, 20000, Thailand

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Muang,, 55000, Thailand

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Nonthaburi, 11000, Thailand

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Pathum Thani, 12120, Thailand

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Cherkasy, 18009, Ukraine

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Chernihiv, 14034, Ukraine

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Chernivtsi, 58000, Ukraine

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Dnipro, 49074, Ukraine

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Ivano-Frankivsk, 76012, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kharkiv, 61035, Ukraine

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Kharkiv, 61039, Ukraine

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Kharkiv, 61058, Ukraine

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Kharkiv, 61075, Ukraine

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Kherson, 73000, Ukraine

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Kyiv, 02091, Ukraine

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Kyiv, 03037, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04050, Ukraine

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Lutsk, 43000, Ukraine

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Lviv, 79066, Ukraine

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Odesa, 65025, Ukraine

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Odesa, 65114, Ukraine

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Ternopil, 46000, Ukraine

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Uzhhorod, 88000, Ukraine

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Uzhhorod, 88009, Ukraine

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Uzhhorod, 88014, Ukraine

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Vinnytsia, 21001, Ukraine

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Zaporizhzhya, 69063, Ukraine

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Zaporizhzhya, 69068, Ukraine

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Can Tho, 900000, Vietnam

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Hanoi, 100000, Vietnam

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Hà Nội, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Hochiminh, 700000, Vietnam

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Huế, 530000, Vietnam

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Related Publications (4)

  • FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6.

  • Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.

  • O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4.

  • Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30.

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Stefan Ivanov
Organization
AstraZeneca AB

Study Officials

  • Carin Jorup, MD

    AstraZeneca Research & Development

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 25, 2014

Study Start

November 28, 2014

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

November 25, 2019

Results First Posted

November 25, 2019

Record last verified: 2019-11

Locations