ADOPT: Airways Disease-Optimisation of Pharmaco-Therapy in lung cancer
| ISRCTN | ISRCTN12205188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12205188 |
| Secondary identifying numbers | ADOPT Version 1.2.2 |
- Submission date
- 25/11/2010
- Registration date
- 28/02/2011
- Last edited
- 03/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Mary O'Brien
Scientific
Scientific
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
 ORCID ID |
0000-0002-0474-9671 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN12205188_PIS_V2_04Jul13.pdf |
| Scientific title | 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) |
| Study acronym | ADOPT |
| Study objectives | We hypothesise that undiagnosed COPD is common in breathless patients with lung cancer and identification and optimisation of their treatment with inhaled therapy (locally-acting bronchodilators and corticosteroids) may improve breathlessness beyond that achievable with best supportive care. |
| Ethics approval(s) | South East Research Ethics Committee, 13/10/2010, ref: 10/H1102/66 |
| Health condition(s) or problem(s) studied | Lung cancer, Chronic obstructive pulmonary disease (COPD) |
| Intervention | 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. Seretide Accuhaler 50 microgram/500 microgram inhaler one inhalation twice a day. These therapies in combination are the mainstay of symptomatic management in patients with COPD. Each patient will remain on study medication for 4 weeks. 2. Control group: Treatment as usual |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Proportion of patients who have a ≥ 2 point change in their Visual Analogue Scale (VAS) for dyspnoea at 4 weeks |
| Secondary outcome measures | 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) |
| Overall study start date | 01/10/2009 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/01/2011 |
| Date of final enrolment | 23/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Royal Marsden Hospital
Down's Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
Royal Marsden Hospital
203 Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Chelsea
London
SW3 6JJ
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Down's Road
Sutton
Surrey
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Government
The Royal Marsden NHS Foundation Trust (UK) - Alan J Lerner Lung Research Fund
No information available
Results and Publications
| Intention to publish date | 22/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The initial results were displayed as a poster at the World Lung Cancer Conference in Yokohama, Japan in October 2017. Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date . |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2 | 04/07/2013 | 04/12/2017 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN12205188_PIS_V2_04Jul13.pdf
- Uploaded 04/12/2017
Editorial Notes
03/09/2018: The overall trial end date was changed from 22/08/2017 to 30/09/2016.
04/12/2017: The following changes were made:
1.The overall trial start date was changed from 01/01/2011 to 01/10/2009.
2. The recruitment start date was changed from 01/01/2011 to 28/01/2011.
3. The recruitment end date was changed from 01/01/2013 to 23/06/2016.
4. The overall trial end date changed from 01/01/2013 to 22/08/2017.
5. A trial participating centre, sponsor address, publication plan, publication date, participant level data and patient information sheet were added.
16/11/2017: No publications found in PubMed, verifying study status with principal investigator.
