Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001278921
Ethics application status
Approved
Date submitted
11/12/2011
Date registered
13/12/2011
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Date results provided
11/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated Problem Based Management of Obstructive Airways Disease in Older people
Scientific title
Integrated Problem Based Management of Obstructive Airways Disease in Older people with Asthma and Chronic Obstructive Pulmonary Disease (COPD) and its impact on quality of life.
Secondary ID [1] 273541 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma and Chronic Obstructive Pulmonary Disease (COPD) 279342 0
Condition category
Condition code
Respiratory 279526 279526 0 0
Chronic obstructive pulmonary disease
Respiratory 279527 279527 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of individualised management based on the baseline multidimensional assessment. A personalised care plan is developed by the study physician and study co-ordinator. The clinicians and participants agree on the tailored interventions for each of the identified problems. An inflammometry algorithm is used to inform treatment decisions for airway and systemic inflammation and mucus hypersecretion. Other tailored interventions are standardised according to best available evidence . A case manager coordinates the plan. The interventions are delivered over the first 3 months during several individualised visits. Participation in pulmonary rehabilitation occurs concurrently.
The tailored interventions are standardised according to best available evidence and will include: optimal medical management including tailoring pharmacotherapy according to airway and systemic inflammation and guiding the exacerbation plan, individualised smoking cessation counseling and pharmacotherapy, management of anxiety and depression, management of mucous hypersecretion, exacerbation management, management of dysfunctional breathing, correction of nutritional and metabolic disorders, implementation of domiciliary oxygen, self management education and support, management of airflow obstruction and co-morbidities, correction of adherence, exercise training, treatment of infection, management of dyspnea, symptoms and patient identified problems.

Pharmacotherapy tailored to airway inflammation (AI)
Macrolide Antibiotics for the treatment of neutrophilic bronchitis. Participants with a sputum neutrophil count greater than 61% and a productive cough are treated with oral Azithromycin 250mg three times weekly.

Corticosteroid therapy for eosinophilic bronchitis
The treatment algorithm published by Siva is used to guide any changes to the maintenance ICS dose.

Allergic Aspergillosis
Assessment: total IgE, aspergillus specific IgE
Intervention: Participants with with a clinical diagnosis of Allergic Bronchopulmonary Aspergillosis are treated with (oral)Itraconazole 200mg daily for 16 weeks

Systemic Inflammation: Serum CRP is measured. Systemic inflammation is defined as CRP>3mg/l. In the absence of any contraindications these participants are treated with oral simvastatin 20mg nocte.

Individualised Self Management education
Intervention: Information about the pathophysiological changes related to their airways disease, guidance in appropriate symptom recognition and assisted with behavioral change strategies to improve outcomes.

In addition to this participants are given an individualized written self management plan with instruction for the management of exacerbations, have their inhaler device skills assessed, reviewed and corrected and adherence assessed and corrected.

Tailored Pulmonary Rehabilitation
Participants attend a Pulmonary Rehabiltation programme involving an 8 week exercise and education programme.

Breathing Strategies
Intervention: A range of different breathing techniques are taught including pursed lip breathing, active expiration, diaphragmatic breathing, adapting specific body positions, and coordinating paced breathing with activities.

Muco-ciliary clearance
Assessment: We screen for the presence of mucus hypersecretion by patient report using a validated assessment of mucus hypersecretion. A volume of greater than 25mls of mucus produced per day is used to define mucus hypersecretion as a problem.
Intervention: Review by a physiotherapist for assessment and instruction in the use of devices (PEP, Accapella, Pari pep or Flutter) to assist with muco-ciliary clearance (MCC). In those with excessive secretions, nebulised hypertonic saline 6% 10mls is used.

Cardiac Failure
Assessment: BNP is measured in all patients.
Intervention: Participants will be managed according to Australian heart failure guidelines.

Anxiety management
Assessment: The Hospital Anxiety and Depression Scale (HADS) A score of > 8 in either domain indicates possible anxiety or depression.
Intervention: Patient are taught how to recognise symptoms of stress and panic and how to implement stress management strategies. Relaxation methods are taught and supplementary audiovisual material provided for use at home.

Management of nutritional and metabolic disorders
3 pronged intervention tailored to BMI.
All receive an individualised dietetic intervention, delivered by a dietitian. Advice: the components of a balanced diet, promoting anti-inflammatory foods high in Omega 3 fatty acids, antioxidants and calcium for bone health.
Underweight –Healthy intervention plus nutritional supplements and counselling. Dietetic information regarding weight gain, including a high protein (1.2-1.5g Protein per Kg Ideal Body Weight), high energy (120% of Estimated Energy Requirements) eating plan and a nutritionally complete oral supplement (Two Cal HN, Abbott Nutrition and/or Sustagen Hospital Formula, Novartis Nutrition).
Overweight – Healthy intervention plus dietetic intervention that focused on weight reduction/weight maintenance through a non very low calorie diet. ‘Lose it Fast’

Osteoporosis: Dual-energy x-ray absorptiometry (DXA) is performed. Pharmacotherapy based on the Australian Osteoporosis guidelines
Smoking: Counselling plus Nicotine Replacement therapy (topical) or oral Varenicline

The overall duration of this study is 2 years.
Intervention code [1] 283852 0
Treatment: Drugs
Intervention code [2] 283853 0
Treatment: Devices
Intervention code [3] 283854 0
Rehabilitation
Comparator / control treatment
Usual Care
Usual care involves guideline based management including medical assessment by a respiratory physician and referral to a standard pulmonary rehabilitation programme in a community based setting. The participant’s usual specialist physician provides a medical assessment, a review a co-morbidities, an assessment of lung function and oxygenation by spirometry and pulse oximetry, and a diagnosis. The treating physician schedules follow up appointments as they deem appropriate.

The treating physician arranges a referral to a community based pulmonary rehabilitation programme. This programme has been developed based on the intervention group programme and includes a baseline assessment by a pulmonary nurse which include a 6 minute walk, spirometry, assessment of SaO2, a social assessment, assessment of smoking status and brief advice, screening for anxiety and depression and a medication and skills assessment. This is followed by an 8 week twice weekly multidisciplinary education and supervised exercise programme with prescription of a home exercise programme (pulmonary rehabilitation).
Control group
Active

Outcomes
Primary outcome [1] 286095 0
Health Status measured by the St George Respiratory Questionnaire
Timepoint [1] 286095 0
3, 6, 12 and 24 months
Secondary outcome [1] 295118 0
Number of clinical problems
This is assessed using a previously developed and published multidimensional assessment. This number of problems identified is summed to give the total number of problems.
The clinical assessments include: Dual energy X-ray absorpitomerty, spiromerty, sputum induction, exhaled nitric oxide, blood collection (serum for C Reactive Protien, full blood count and Brain natriuretic peptide), 6 minute walk test, questionnaires, assessment of inhaler technique and exhaled carbon monoxide.
Timepoint [1] 295118 0
3, 6, 12 and 24 months
Secondary outcome [2] 295119 0
Peripheral blood will be collected and C Reactive Protien (CRP) measured from serum by ELISA
Timepoint [2] 295119 0
3, 6, 12 and 24 months
Secondary outcome [3] 295121 0
Sputum eosinophils and neutrophils

Induced sputum is collected by inhalation of nebulised hypertonic saline or normal saline. The saline is delivered using a mouthpiece and two-way valve connected to an ultrasonic nebuliser. A short-acting beta2 agonist (SABA) is administered via pressurised metered dose inhaler (pMDI) and valved holding chamber prior to the induction commencing. Saline is delivered via the ultrasonic nebuliser in time incremental intervals (30 seconds, 1 minutes, 2 minutes, and 4 minutes x 2). One minute after each saline dose, airway calibre is assessed by lung function and participants are instructed to vigorously cough, huff and empty the expectorant into a sterile container. If at any time the FEV1 falls below 15% of baseline, further SABA is administered.
Airway inflammation is assessed using induced sputum. Lower respiratory sputum portions are selected from saliva, processed using dithiothreitol and differential cell counts obtained.
Timepoint [3] 295121 0
3, 6, 12 and 24 months
Secondary outcome [4] 295122 0
Lung Function
Airflow obstruction is assessed in each participant using spirometry (KoKo K313100 PDS Instrumentation, Louisville, CO, USA) to measure pre and post bronchodilator FEV1, FVC and FEV1/FVC%. Predicted FEV1 and FVC are calculated using NHANES III
Timepoint [4] 295122 0
3, 6, 12 and 24 months

Eligibility
Key inclusion criteria
>55 years
pre bronchodilar FEV1 <80%, FER <0.7
Doctor diagnosed COPD or Asthma
Disease stability in the previous 4 weeks
Participants are postponed if they have required antibiotics or oral corticosteroids for an acute exacerbation of their airways disease within the previous month, or if they are experiencing a current acute illness.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded if they have a malignancy, or a significant co-morbidity that the study visits and interventions may impact on or have a poor prognosis with an anticipated life expectancy of <3 months. Participants must be able to attend the visits and have satisfactory written and verbal English language skills

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who consent to the study and live outside the JHH PR catchment area act as the control. The consenting participants referred John Hunter Hospital receive the intervention. Allocation to usual care or IPBM is independent of the physician and patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2009
Actual
24/07/2009
Date of last participant enrolment
Anticipated
Actual
21/01/2011
Date of last data collection
Anticipated
Actual
15/11/2011
Sample size
Target
40
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284327 0
University
Name [1] 284327 0
The University of Newcastle
Country [1] 284327 0
Australia
Funding source category [2] 284328 0
Hospital
Name [2] 284328 0
John Hunter Hospital
Country [2] 284328 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked bag 1 HRMC, 2310, NSW
Country
Australia
Secondary sponsor category [1] 283270 0
University
Name [1] 283270 0
The University of Newcastle
Address [1] 283270 0
Univeristy Drive, Callaghan, 2308, NSW
Country [1] 283270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286288 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286288 0
Ethics committee country [1] 286288 0
Australia
Date submitted for ethics approval [1] 286288 0
31/07/2008
Approval date [1] 286288 0
20/09/2008
Ethics approval number [1] 286288 0
08/08/20/3.10
Ethics committee name [2] 286319 0
The University of Newcastle
Ethics committee address [2] 286319 0
Ethics committee country [2] 286319 0
Australia
Date submitted for ethics approval [2] 286319 0
Approval date [2] 286319 0
22/01/2009
Ethics approval number [2] 286319 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33501 0
Prof Vanessa McDonald
Address 33501 0
Level 2, Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 33501 0
Australia
Phone 33501 0
+61 2 4042 0146
Fax 33501 0
Email 33501 0
[email protected]
Contact person for public queries
Name 16748 0
Kelly Steel
Address 16748 0
Department of Respiratory and Sleep Medicine
John Hunter Hospital
Locked bag 1 HRMC 2310, NSW
Country 16748 0
Australia
Phone 16748 0
+61249213470
Fax 16748 0
Email 16748 0
[email protected]
Contact person for scientific queries
Name 7676 0
Vanessa McDonald
Address 7676 0
John Hunter Hospital
Locked Bag 1 HRMC 2310, NSW
Country 7676 0
Australia
Phone 7676 0
+61249213470
Fax 7676 0
Email 7676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised demographic and primary outcome data underlying published results
When will data be available (start and end dates)?
Following publication - no end date
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Individual patient data meta-analysis
How or where can data be obtained?
Access subject to approvals by Principal Investigator
Professor Vanessa McDonald 02 40420146


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.