Chronic obstructive pulmonary disease, lung cancer
Conditions
Interventions
Trade Name: VentolinTM EvohalerTM
Product Name: VentolinTM EvohalerTM.
Pharmaceutical Form: Inhalation vapour*
Trade Name: SPIRIVA® 18 microgram, inhalation powder, hard capsule
Product Name: SPIRIV
Sponsors
Royal Marsden Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Patients with hypersensitivity to any of the study drugs, lactose allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether optimisation of inhaler therapy in patients with lung cancer and co-existing COPD improves breathlessness (an increase in the proportion of patients with COPD and Lung cancer who have an improvement in their their visual analogue scale for breathlessness) at 4 weeks compared to best supportive care. ;Secondary Objective: To investigate whether the optimisation of inhaler therapy in patients who have lung cancer and co-existing COPD: a. Improves the distance that they are able to walk in 6 minutes (6 minute walk test - 6MWT)at 2 weeks and 4 weeks from commencing the inhalers; b. Improves forced expiratory volume in 1 second (FEV1) at 2 weeks and 4 weeks from commencing inhalers. FEV1 is a measure of the ability of patients to breathe out (expiration). FEV1 can be used to determine the severity of COPD c. Improve peak expiratory flow rate (PEFR) at 2 weeks and 4 weeks. PEFR is measure of the ability of patients to breath out fast. d. Improves quality of life using (using a quality of life questionnaire)at 4 weeks; e. Improves level of physical activity at 4 weeks (using a questionnaire) 2. To investigate and describe the relationship of breathlessness and COPD in patients with lung cancer. 3. To investigate and describe any relationship between breathlessness and the position of the tumour in;Primary end point(s): To investigate whether optimisation of inhaler therapy increases the proportion of patients who have a >/= 2 point change in their visual analogue scale (VAS) for dyspnoea (breathlessness) at 4 weeks compared to best supportive care. | — |
Countries
United Kingdom
Outcome results
None listed