An interventional study of Tiotropium and Formoterol in Chronic Obstructive Pulmonary Disease, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
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Among 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive — none open to participants now, none under way, none of them phase 3. tiotropium · Pulmonary Disease, Chronic Obstructive.
Among the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive, this one is the 57th largest by planned enrollment, is one of 9 that started in 2017, is one of 5 with no phase, and was the 94th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →None of the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive is open now. The open studies under Pulmonary Disease, Chronic Obstructive, anywhere →
tiotropium: first FDA approval 2004 (SPIRIVA). What it is approved for, and how studies give it, is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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105 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 131 across the 105 interventional studies. Of the 97 that completed or were terminated, 40 (41%) have results posted.
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74 of 105 have an industry lead sponsor. The 10 most frequent:
Huashan Hospital is the lead sponsor of 248 studies on the registry; 105 are open to participants now.
Huashan Hospital has 3 studies filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive, from their registry updates:
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Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent airflow limitation and associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. As a major public health problem, COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus, prevention of exacerbations is a important goal in the management of COPD. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint project in 1998. Its goals were to raise awareness of COPD and to improve prevention and treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD patients. However, it is not known whether LABA or LAMA will be more effective for initial relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the secondary endpoints include the frequency of COPD exacerbation, other lung function parameters, CCQ score and mMRC/CAT score.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of group A or group B stable . Must be able to inhale Formoterol or Tiotropium.
Exclusion Criteria:
Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
inhaled formoterol(4.5μg, bid)
Drug: Formoterol
inhaled Tiotropium(18μg, qd)
Drug: Tiotropium
inhaled Tiotropium(18μg, qd)
inhaled formoterol(4.5μg, bid)
postbronchodilator FEV1
a post-bronchodilator forced expiratory volume in one second
Time frame: 12 months
the frequency of COPD exacerbation
the frequency of COPD exacerbation
Time frame: 12 months
other lung function parameters
other lung function parameters(%FEV1, FEV1/FVC)
Time frame: 12 months
CCQ score
Clinical COPD Questionnaire score
Time frame: 12 months
mMRC score
modified Medical Research Council score
Time frame: 12 months
CAT score
COPD Assessment Test score
Time frame: 12 months
Start is estimated for Nov 2017; primary completion for Aug 2018, 9 months later.
Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 9 months is below that.
Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tiotropium
Pulmonary Disease, Chronic Obstructive →