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Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients.

Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients. - OPH-R-COPD-1402

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014303
Enrollment
22
Registered
2014-06-26
Start date
2014-06-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

glycopirronium inhalation therapy

Sponsors

Department of Respiratory Medicine, Osaka Police Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 40 years-old or older 2. A history of cigarette smoking or excessive exposure to smoke. 3. Clinically stable moderate-to-severe COPD, according to the Global Initiative on Obstructive Lung Disease (GOLD) staging. 4. Never treated with long-acting beta-agonists (LABA) or more than 4 weeks after last LABA inhalation. 5. Never treated with long-acting muscarinic antagonists (LAMA) or more than 4 weeks after last LAMA inhalation. 6. Able to walk independently or with a cane. 7. Sufficient cognitive function to follow the instructions for using the pulse oximetry equipment and accelerometers. 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 2. Closed angle glaucoma 3. Severe urination disorder 4. A history of hypersensitivity reaction against glycopirronium 5. A recent history of respiratory infection and acute exacerbation in the previous one month. 6. Clinically severe athma. 7. Other significant cardiac diseases or medical problems precluding ambulatory activity at hom 8. Physician's decision.

Design outcomes

Primary

MeasureTime frame
Proportion of activity intensity of 1 or more, accessed by accelerometer.

Secondary

MeasureTime frame
1. Pulmonary functions; FVC, FEV1,FEV1%, V50, V25 2. QOL and activity ; CAT, SF-36, modified MRC 3. Physical activity; calorie consumption, steps, amount of exercise 4. Arterial blood test; PaO2, PaCO2 5. Exacerbation episode

Countries

Japan

Contacts

Public ContactSeigo Minami

Osaka Police Hospital Department of Respiratory Medicine

seigominami@oph.gr.jp81-6-6771-6051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026