None listed
Conditions
Brief summary
This is a pragmatic 2x2 factorial cluster randomized trial, involving two different components: (a) for patients with recurrent obstructive lung disease: a chronic respiratory disease component evaluating the effect of a stepped algorithm involving budesonide-formoterol against standard care. This trial will use the single inhaler medication for undifferentiated obstructive lung disease (i.e. asthma or COPD) in order to simplify the algorithm, and therefore optimise the effectiveness of the medication for patients presenting with recurrent respiratory symptoms. (b) for patients who are current smokers: a smoking cessation component evaluating the effect of a brief counseling intervention (delivered via an outpatient smoking cessation quitline) against standard care (without outpatient counseling).
Interventions
This is a two-by-two factorial cluster randomised trial, and hence there are two independent interventions. Different populations of patients may receive the two interventions. The enrolment period is 12 months for all participants.
The first (Intervention 1) is a stepped chronic respiratory disease intervention, which provides increasing doses of inhaled corticosteroid- long acting beta agonist therapy to patients according to their symptom control. The second (Intervention 2) is a smoking ces
This is a two-by-two factorial cluster randomised trial, and hence there are two independent interventions. Different populations of patients may receive the two interventions. The enrolment period is 12 months for all participants. The first (Intervention 1) is a stepped chronic respiratory disease intervention, which provides increasing doses of inhaled corticosteroid- long acting beta agonist therapy to patients according to their symptom control. The second (Intervention 2) is a smoking cessation intervention using brief counseling and outpatient smoking cessation counselling using a Quitline. INTERVENTION 1 (chronic respiratory disease management intervention): A stepped chronic respiratory disease (CRD) management intervention, comprising three steps. The active drug is inhaled budesonide-formoterol via Turbuhaler (200-6mcg per dose). All participants begin on Step 1. The treatment step will be individualised: at scheduled reviews, they may be stepped up or down on their therapy according to their symptom control - which is assessed using a standardised questionnaire. Treatment is delivered through the government District Health Clinics, in participating Districts. This treatment replaces usual care. The steps in the intervention group are: (a) Step 0: No inhaler therapy. (b) Step 1 (the initial step, for participants in the intervention group at enrolment): As needed budesonide-formoterol 200-6mcg, with one (1) dose as needed (maximum 12 inhalations in any one day) (c) Step 2: Budesonide-formoterol 200-6mcg one (1) dose twice daily AND one (1) dose as needed budesonide-formoterol 200-6mcg one (1) when respiratory symptoms are worse than usual (up to 10 additional inhalations per day, i.e. a total maximum of 12 inhalations per day). (d) Step 3: Refer to specialist care for further assessment, comprising referral for a clinical consultation +/- a telephone consultation with a medical advisor. Participants will begin at Step 1, at the time of enrolment. During each clinical assessment, participants will be advised to (a) remain on the current step, or (b) step up or (c) step down based upon their symptom control, and whether an exacerbation has occurred. Patients using an AVERAGE of more than 6 inhalations per day (i.e. less than 20 days between inhaler dispensings) will be identified for clinical review in person or by phone by a medical advisor or study doctor. Medications will be brought by participants to each visit in order to evaluate cumulative treatment. The number of doses used will be determined based upon the counter on the inhaler. Scheduled reviews for this group will be conducted by a doctor at the health facility. After enrolment, follow-up will occur after 28 days (+/- 7 days), taking approximately 30 minutes. Scheduled follow-up by the health facility doctor lasting 30 minutes will occur at 3, 6, 9 and 12 months. INTERVENTION 2: A health system smoking cessation (SC) intervention Individuals allocated to the intervention group will receive brief counselling lasting approximately 5 minutes from healthcare workers at government District Health Clinics, according to the '5As' approach (Ask, Assess, Advise, Assist and Arrange). This treatment replaces usual care. They will then be referred to an outpatient Smoking Cessation Call Centre, established for this study. The call centre staff will make contact with them by telephone within 24-48 hours after referral. They will then be offered regular follow-up by the Smoking Cessation Call Centre five times in the first 60 days (e.g. days 7, 14, 21, 28, 60, according to patient availability). Each phone call will include brief advice about cessation lasting approximately 15 minutes, based upon the participant's readiness to quit. Participants will be followed 3, 6 and 9 months by telephone by research staff to monitor their smoking status - with no additional delivery of counselling. After 12 months, participants will be called by research staff and asked about their current smoking status, in a call lasting approximately 10 minutes. Patients who state they are non-smokers will invited to submit a sample of sputum or urine for cotinine testing to confirm the non-smoking status.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the chronic respiratory disease (CRD) component: (a) Patients 12 years old and over, presenting to district health facilities; AND: (b) Presents with at least one of cough, dyspnoea, wheeze or chest tightness, AND (c) A history of at least one prior episode of respiratory symptoms requiring assessment by a health care facility (clinic, private doctor, pharmacy or hospital) in the past 24 months; AND (d) Intends to be resident in the Province for the next 12 months (e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative) and (f) Meets the definition for asthma or COPD, as defined by: (i) Probable asthma: Score of three or more “YES” responses (out of a total of 9) on the Asthma questionnaire) , OR (ii) Airflow limitation: either pre-bronchodilator FEV1/FVC ratio < 70% OR (contraindicated or cannot be performed) Peak Expiratory Flow (PEF) <80% predicted at time of presentation; Inclusion criteria for the smoking cessation (SC) component: (a) Patients attending the selected health facility AND (b) Aged 12 years and over; AND (c) A current smoker (either occasional or daily); AND (d) Intends to be resident in the Province for the next 12 months; AND (e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative)
Exclusion criteria
Exclusion criteria for screening: (a) Patient cannot provide consent (e.g. due to confusion or dementia) (b) The patient has respiratory failure (e.g. hypoxaemia requiring supplemental oxygen) (c) The patient is haemodynamically unstable (d) Patient currently has active tuberculosis (e) The patient has a history of bronchiectasis, defined as daily cough and production of purulent sputum for at least 6 months. (f) Patient has one of the following serious health conditions: aortic aneurysm, current cancer, an illness with a prognosis of <1 year (g) Allergic to budesonide or formoterol (h) Patient is currently pregnant (i) Patients will not be enrolled if a probable alternative diagnosis explains the respiratory symptoms. Exclusion criteria for the SC component: (a) Unable to give informed consent, with difficulty with communication or severe mental illness.
Outcome results
None listed