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Observation on the clinical efficacy of glononium bromide formoterol inhalation aerosol in Group B patients with stable chronic obstructive pulmonary disease with CAT score less than 20

Observation on the clinical efficacy of glononium bromide formoterol inhalation aerosol in Group B patients with stable chronic obstructive pulmonary disease with CAT score less than 20

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110763
Enrollment
Unknown
Registered
2025-10-20
Start date
2023-07-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

COPD

Interventions

Experimental Group:Grononium bromide formoterol inhalation aerosol ,Twice a day
Control group:Tiotropium bromide powder aerosol inhalation aerosol 18 µ g,once a day

Sponsors

Zitong County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with COPD in accordance with the guidelines of the Global initiative for chronic obstructive pulmonary Disease, aged 40 years or older,<= 80 years old (2) There was no history of acute exacerbation of COPD in the year prior to the visit, or the acute exacerbation occurred once but was relieved without hospitalization (3) Patients can cooperate with pulmonary function tests and complete CAT scores and mMRC questionnaires (4) COPD Group B 10 points <= CAT score < 20 points; (5) Comply with the requirements of the ethics committee, sign the informed consent form, voluntarily use the drug and accept follow-up observation (6) Initial treatment patients; No maintenance bronchodilator treatment was received from 30 days before screening to the first study treatment period

Exclusion criteria

Exclusion criteria: (1) Make a clear diagnosis of asthma patients (2) Patients with significant respiratory diseases other than COPD (3) Patients with other clinically significant uncontrolled diseases (such as severe heart disease, severe hypertension, etc.);Women who are pregnant, breastfeeding or planning to become pregnant during the study period (4) Those who are known or suspected of being allergic to any 2 receptor agonists, M receptor blockers, or investigational drugs; (5) Unhealed oral diseases, such as oral ulcers, oral mucosal damage, oropharyngeal candidiasis, etc.

Design outcomes

Primary

MeasureTime frame
FEV1;

Secondary

MeasureTime frame
FVC;mMRC;CAT;SPO2;Increase the number of people;Adverse events;

Countries

china

Contacts

Public Contactlin yang

Zitong County People's Hospital

1581360393@qq.com+86 181 6101 4818

Outcome results

None listed

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