Skip to content

A 18-week, randomized, double-blind, controlled crossover design study to assess the combination with tiotropium treatment in asthma treatment based on Class IV non-eosinophilic patients with severe asthma efficacy and safety

A 18-week, randomized, double-blind, controlled crossover design study to assess the combination with tiotropium treatment in asthma treatment based on Class IV non-eosinophilic patients with severe asthma efficacy and safety

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOC-15006325
Enrollment
Unknown
Registered
2015-04-30
Start date
2015-05-01
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

asthma

Interventions

1:tiotropium
2:Placebo

Sponsors

Respiratory Department, Xinqiao Hospital (2nd Affiliated Hospital) of Third Military University, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Before any assessment, must sign an informed consent; 2. Male or female adults aged between 18-75 years old; 3. Under the existing GINA strategy (GINA2014), patients were diagnosed with asthma, and there is reversible within 1 year test positive result; 4. Use salbutamol 400ug (via a spacer inhalation) 30 minutes after the FEV1% post <80%; 5. 1 patient visits within 3 months before the law to accept the GINA recommendation Class IV treatment can not achieve asthma control; 6. The proportion of induced sputum eosinophils category <3%.

Exclusion criteria

Exclusion criteria: 1. associated with chronic obstructive pulmonary disease; 2. Before the patient visits a three-month internal any reason, systemic corticosteroid therapy, and treatment >7 days; 3. Patients with a prior visit occurred within 4 weeks of respiratory tract infections; 4. bronchiectasis patients with clinically significant or other clinically significant respiratory system and other system disorders; 5. Known for possible treatment of patients with drug allergy; 6. A pregnant or lactating women; 7. patients can not use a single dose dry powder inhaler device; 8. investigators determine poor patient compliance or other diseases are not suitable to participate in this study; 9. In a visit within the first 30 days or 5 half-lives (in a longer time) had used other experimental drugs; 10. The angle-closure glaucoma, symptoms of an enlarged prostate or bladder neck obstruction, creatinine clearance <50ml/ml in patients.

Design outcomes

Primary

MeasureTime frame
Morning peak FEV1;

Countries

China

Contacts

Public ContactWang Changzheng
czwang@netease.com+86 13983815706

Outcome results

None listed

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