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Randomized controlled study on combination therapy of tiotropium bromide and sustained-release theophyline for moderate stable COPD

Randomized controlled study on combination therapy of tiotropium bromide and sustained-release theophyline for moderate stable COPD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-07000177
Enrollment
Unknown
Registered
2007-12-12
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (moderate stable stage)

Interventions

Group A:Tiotropium bromide 18ug inhalation Qd + Placebo 0.2 g oral B.i.d.
Group B:Tiotropium bromide 18ug inhalation Qd + sustained-release theophyline 0.2 oral-taking Bid

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with the diagnosis of moderate stable COPD (according to the diagnosis and treatment guidelines for COPD established by Chinese Medical Association in 2007) and presentation of dyspnea.

Exclusion criteria

Exclusion criteria: 1. With other disease that may cause airflow obstruction (bronchial asthma, bronchiestasis, pulmonary tuberculosis, diffuse panbronchiolitis, et al); 2. Respiratory tract infection within 2 weeks and in 2 weeks of washout; 3. Allergic to anticholinergic agents, theosine, lactose, et al; 4. Narrow angle glaucoma; 5. Hyperplasia of prostate gland with obvious symptoms; 6. Bladder orifice stricture; 7. Long-term use of glucocorticoids, long-actingß-adrenergic receptor agonists, leukotriene antagonists, antihistamine drugs and antibiotics; 8. Dysfunction of heart, liver, kidney or lung; 9. Pregnant or breast-feeding women; or women of childbearing age without contraception; 10. History of alcohol, drugs and drugs addiction or other factors influencing the compliance.

Design outcomes

Primary

MeasureTime frame
Quality of life;Side effects;Lung function;

Countries

China

Contacts

Public ContactHongmei Yue
wxy750519@163.com+86 0931-8625200-6641

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026