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Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery

Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery - Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014361
Enrollment
120
Registered
2014-06-25
Start date
2014-07-01
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

Primary lung cancer

Interventions

Inhalation of Salmeterol, 50 microgram twice daily, starting from 10 days before the surgery. No inhalation of Salmeterol.

Sponsors

Yamanashi Prefectural Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Clinically suspected or diagnosed primary lung cancer. 2)FEV1.0/FVC < 0.70, assessed by spirometry. 3)Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I-III. 4)Modified Medical Research Council (MRC) score =<1. 5)Resectable cancer lesion by single lobectomy. 6)No previous treatment of COPD or asthma. 7)No past history of pulmonary resection. 8)Patients being able to stop smoking at the time of the registry to this trial. 9)Adequate organ function tolerable for the general anesthesia. 10)Capable for inhalation. 11)Age of 20 years or older. 12)ECOG performance status: 0, 1 13)Written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1)Median sternotomy. 2)Combined resection of the chest wall. 3)Active infection. 4)Active double cancer. 5)Current or previous history of severe heart diseases or cerebrovascular disases. Uncontrolled diabetes mellitus or hypertension. Interstitial pneumonia. Arrhythmia requiring antiarrhythmic continuously. Renal dysfunction necessitating blood purification therapy. 6)Patients with psychiatric disease. 7)Patients requiring systemic steroids medication. 8)Pregnant and lactating female, female who has possibility of pregnancy. 9)Past history of drug allergy. 10)Hypokalemia. 11)Patients who were judged inappropriate to enter this trial by physician.

Design outcomes

Primary

MeasureTime frame
Improvement of pulmonary function associated with inhalation of Salmeterol

Secondary

MeasureTime frame
1) Rate of postoperative complications 2) Self-assessment of respiratory insufficiency 3) 1-year overall survival 4) Rate of adverse events 5) Evaluation of postoperative compliance

Countries

Japan

Contacts

Public ContactTaichiro Goto

Yamanashi Prefectural Central Hospital General Thoracic Surgery

taichiro@1997.jukuin.keio.ac.jp055-253-7111

Outcome results

None listed

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