Condition category
Respiratory
Date applied
25/11/2010
Date assigned
28/02/2011
Last edited
04/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Mary O'Brien

ORCID ID

http://orcid.org/0000-0002-0474-9671

Contact details

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADOPT Version 1.2.2

Study information

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)

Acronym

ADOPT

Study hypothesis

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

South East Research Ethics Committee, 13/10/2010, ref: 10/H1102/66

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2009

Overall trial end date

22/08/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant 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

Recruitment start date

28/01/2011

Recruitment end date

23/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Marsden Hospital
Down's Road
Sutton
SM2 5PT
United Kingdom

Trial participating centre

Royal Marsden Hospital
203 Fulham Road Chelsea
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Down's Road
Sutton
Surrey
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The Royal Marsden NHS Foundation Trust (UK) - Alan J Lerner Lung Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement: The data sharing plans for the current study are unknown and will be made available at a later date .

Intention to publish date

22/08/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.