EUCTR2010-021412-42-GB
Active, not recruiting
Phase 1
Prospective randomised controlled trial to investigate the effectiveness of inhalers for the relief of breathlessness in patients with lung cancer and COPD - Airway disease optimisation of pharmaco-therapy in lung cancer
Royal Marsden Hospital0 sites65 target enrollmentOctober 8, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease, lung cancer
- Sponsor
- Royal Marsden Hospital
- Enrollment
- 65
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female, age \> 35 years
- •2\.Diagnosis of lung cancer ( Non\-small cell lung cancer, Small cell lung cancer and mesothelioma)
- •3\.Diagnosis of chronic obstructive pulmonary disease (COPD)
- •4\.Subjective dyspnoea (breathlessness) of VAS score \>/\= 4
- •Are the trial subjects under 18?
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years)
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Involvement in any other studies of breathlessness
- •2\.Reversible causes of breathlessness
- •3\.Patients receiving radiotherapy, chemotherapy, biological therapy or surgery. Or with a plan to commence these treatments within 4 weeks
- •4\.Current use of bronchodilators either inhaled or oral (aminophyline, methyxanthines) except for short\-acting bronchodilators
- •5\.Recent change to oral corticosteroid therapy dose (within 1 week of randomisation)
- •6\.Current use of beta\-blockers for any reason
- •7\.Current use of anti\-cholinergic containing drugs
- •8\.Current use of potent CYP30 inhibitors (ritonavir, ketoconazole, itraconazole)
- •9\.Patients with the following conditions: asthma, severe cardiovascular disorders (myocardial infarction within 6 week), heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia, glaucoma, prostate problems, patients with difficulty passing urine, renal failure, TB (current or previous)
- •10\.Pregnancy
Outcomes
Primary Outcomes
Not specified
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