A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
SHINE
A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
2 other identifiers
interventional
2,144
19 countries
166
Brief Summary
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
166 active sites
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
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 3, 2013
CompletedSeptember 9, 2013
August 1, 2013
1.4 years
September 13, 2010
February 7, 2013
August 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Secondary Outcomes (22)
Transitional Dyspnea Index (TDI) Focal Score at Week 26
Week 26
St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
26 weeks
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks
Baseline, Week 26
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
- +17 more secondary outcomes
Study Arms (5)
indacaterol and glycopyrronium (QVA149)
EXPERIMENTALQVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
glycopyrronium (NVA237)
ACTIVE COMPARATORNVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
indacaterol (QAB149)
ACTIVE COMPARATORQAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
tiotropium
ACTIVE COMPARATORTiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Placebo
PLACEBO COMPARATORMatching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Interventions
Capsules for inhalation delivered via SDDPI.
Eligibility Criteria
You may qualify if:
- Male or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
- Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
You may not qualify if:
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (166)
Novartis Investigative Site
Fullerton, California, 92835, United States
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Riverside, California, 92506, United States
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St. Petersburg, Florida, 33707, United States
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Troy, Michigan, 48085, United States
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Minneapolis, Minnesota, 55402, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68134, United States
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Charlotte, North Carolina, 28207, United States
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Columbus, Ohio, 43215, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97213, United States
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Greenville, South Carolina, 29615, United States
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Johnson City, Tennessee, 37601, United States
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Daw Park, Australia
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Glebe, Australia
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Kogarah, Australia
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Nedlands, Australia
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New Lambton, Australia
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Vancouver, British Columbia, Canada
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Burlington, Ontario, Canada
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Courtice, Ontario, Canada
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Mississuaga, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beuvry, France
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Bourges, France
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Ferolles-Attily, France
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Rennes, France
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Berlin, Germany
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Erfurt, Germany
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Geesthacht, Germany
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Hanover, Germany
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Leipzig, Germany
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Minden, Germany
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Witten, Germany
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Guatemala City, Guatemala
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Balassagyarmat, Hungary
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Budapest, Hungary
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Győr, Hungary
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Komárom, Hungary
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Nyíregyháza, Hungary
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Tatabánya, Hungary
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Asahikawa, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Hachiōji, Japan
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Hamakita, Japan
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Himeji, Japan
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Hiroshima, Japan
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Hitachi, Japan
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Iwata, Japan
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Kamogawa, Japan
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Kishiwada, Japan
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Kiyose, Japan
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Kurashiki, Japan
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Matsumoto, Japan
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Matsusaka, Japan
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Minatoku, Japan
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Moriya, Japan
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Nagaoka, Japan
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Nagoya, Japan
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Niigata, Japan
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Obihiro, Japan
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Sakai, Japan
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Sakaidechō, Japan
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Sapporo, Japan
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tabashi City, Japan
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Tachikawa, Japan
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Takatsuki, Japan
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Tsu, Japan
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Yabu, Japan
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Yanagawa, Japan
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Yatsushiro, Japan
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Yonezawa, Japan
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Bulacan, Philippines
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Las Piñas, Philippines
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Manila, Philippines
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Pasay, Philippines
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Quezon City, Philippines
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Krakow, Poland
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Proszowice, Poland
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Tarnów, Poland
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Warsaw, Poland
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Barnaul, Russia
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Kazan', Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Nizhny Novogorod, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Ufa, Russia
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Bardejov, Slovakia
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Bojnice, Slovakia
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Bratislava, Slovakia
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Humenné, Slovakia
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Košice, Slovakia
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Liptovský Hrádok, Slovakia
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Partizánske, Slovakia
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Prievidza, Slovakia
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Spišská Nová Ves, Slovakia
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Trstená, Slovakia
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Zvolen, Slovakia
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Žilina, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Lyttleton, South Africa
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Pretoria, South Africa
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Alzira, Spain
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Badalona, Spain
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Barcelona, Spain
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Canet de Mar, Spain
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Centelles, Spain
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Ferrol, Spain
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Fuenlabrada, Spain
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les Borges del Camp, Spain
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Madrid, Spain
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Mataró, Spain
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Mérida, Spain
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Motril, Spain
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Móstoles, Spain
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Palma de Mallorca, Spain
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Ponferrada, Spain
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Salamanca, Spain
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Salt, Spain
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Valencia, Spain
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Vic, Spain
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Basel, Switzerland
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Lugano, Switzerland
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Münchenstein, Switzerland
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Neuchâtel, Switzerland
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Zurich, Switzerland
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Chai-Yi, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Bolu, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Çanakkale, Turkey (Türkiye)
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Denizli, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Manisa, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Bath, United Kingdom
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Blackpool, United Kingdom
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Bradford, United Kingdom
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Cambs, United Kingdom
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Chelmsford, United Kingdom
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Chesterfield, United Kingdom
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Glasgow, United Kingdom
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Herts, United Kingdom
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Isle of Wight, United Kingdom
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London, United Kingdom
Related Publications (1)
Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.
PMID: 25609942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2010
First Posted
September 15, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
September 9, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-08