ADOPT: Airways Disease-Optimisation of Pharmaco-Therapy in lung cancer

Prospective randomised controlled trial to investigate the effectiveness of inhalers for the relief of breathlessness in patients with lung cancer and chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12205188

Enrollment

Registered

2011-02-28

Start date

2011-01-28

Completion date

Unknown

Last updated

2018-09-24

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

Conditions

Lung cancer, Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease (COPD)

Interventions

Patients will be randomised to one of two groups 1. Intervention group: 1.1. Ventolin Evohaler 100 micrograms, 2 inhalations 4 times a day 1.2. Spiriva 18 micrograms one inhalation a day 1.3. Seretid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, age > 35 years 2. Diagnosis of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) or mesothelioma 3. Diagnosis of COPD 4. Subjective dyspnoea of visual analogue score (VAS) = 4

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 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: 9.1. Asthma 9.2. Severe cardiovascular disorders (myocardial infarction within 6 week) 9.3. Heart rhythm abnormalities 9.4. Thyrotoxicosis 9.5. Uncorrected hypokalaemia 9.6. Glaucoma 9.7. Prostate problems 9.8. Patients with difficulty passing urine 9.9. Renal failure 9.10. TB (current or previous) 10. Pregnancy 11. Patients with hypersensitivity to any of the study drugs, lactose allergy

Design outcomes

Primary

Measure	Time frame
Proportion of patients who have a = 2 point change in their Visual Analogue Scale (VAS) for dyspnoea at 4 weeks	—

Secondary

Measure	Time frame
1. Six-minute walk test (6MWT) at 2 and 4 weeks 2. Forced expiratory volume in 1 second (FEV1) at 2 and 4 weeks 3. Peak expiratory flow rate (PEFR) at 2 and 4 weeks 4. Quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire + Lung cancer module (EORTC C-30 + L13) at 4 weeks 5. Level of physical activity using the St Georges Respiratory Questionnaire (SGRQ) activity scale at 4 weeks 6. To investigate and describe the relationship of breathlessness and obstructive lung disease (% predicted FEV1) in patients with lung cancer 7. To investigate and describe any relationship between breathlessness and the position of the tumour in relation to the bronchial tree (large airway/central Vs peripheral)	—

Measure

Time frame

1. Six-minute walk test (6MWT) at 2 and 4 weeks 2. Forced expiratory volume in 1 second (FEV1) at 2 and 4 weeks 3. Peak expiratory flow rate (PEFR) at 2 and 4 weeks 4. Quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire + Lung cancer module (EORTC C-30 + L13) at 4 weeks 5. Level of physical activity using the St Georges Respiratory Questionnaire (SGRQ) activity scale at 4 weeks 6. To investigate and describe the relationship of breathlessness and obstructive lung disease (% predicted FEV1) in patients with lung cancer 7. To investigate and describe any relationship between breathlessness and the position of the tumour in relation to the bronchial tree (large airway/central Vs peripheral)

—

Countries

United Kingdom

Outcome results

None listed

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