Anti-inflammatory effects of oral and transdermal clonidine in bronchiectasis

The effect of clonidine on sputum cytokines in patients with bronchiectasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001344583

Enrollment

Registered

2015-12-09

Start date

2016-02-22

Completion date

2017-10-16

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Bronchiectasis is a troublesome disease characterised by productive cough, airway inflammation, and repeated bacterial infections requiring antibiotics. The main aim of this study is to assess whether Clonidine can reduce inflammation in the lungs. We will also assess whether similar effects are seen in the bloodstream. We are interested to see if (transdermal) skin patches of Clonidine are better than oral tablets in controlling inflammation, and which treatment is better tolerated. This study will provide important information for the development of a larger study to assess whether Clonidine treatment can prevent symptom flareups(exacerbations) in patients with bronchiectasis. Participants will attend 4 study visits over the 8 week study where they will have their health assessed (vital signs,lung function, sputum and blood samples taken), complete questionnaires and study diaries.

Interventions

Name:Anti-inflammatory effects of oral and transdermal clonidine in bronchiectasis. Dose:150micrograms oral clonidine twice a day or 300micrograms transdermal clonidine once a week. Study Duration: 8 weeks Mode of administration: Oral tablet or transdermal patch Adherance measured by recording returned pill and patch counts at each visit.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

1.Aged greater than or equal to 18 and less than or equal to 90 years 2.Able to provide written informed consent 3.Able to provide spontaneous sputum sample at visit 2 (week 0). 4.High resolution CT scan (HRCT) diagnosis of bronchiectasis; CT scan performed within the past 5 years 5.Clinically stable during baseline period, which is 4 weeks prior to randomisation; (as defined by the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone and stable spirometry) 6.History of at least one pulmonary exacerbation requiring antibiotic treatment in the past 12 months. Patients with asthma and COPD will be included if the primary diagnosis is bronchiectasis.

Exclusion criteria

1.Patients with significant abnormal liver function (AST/ALT greater than 2x upper limit of normal range) or liver cirrhosis (15-30% clonidine is metabolised in the liver) 2.Known history of allergy or reaction to clonidine 3.Systolic blood pressure less than 100 mmHg 4.Bradyarrhythmia due to 2nd or 3rd degree AV block or sick sinus syndrome. 5.Active dermatitis preventing application of a clonidine patch on upper outer arm or chest. 6.Continuous antibiotic therapy (greater than 3 months) 7.Long term macrolide treatment (greater than or equal to 3 months) in the past 6 months Patients taking continuous oral corticosteroids (greater than 6 weeks) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide). 8.Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic or steroid treatment within 4 weeks prior to commencing study drug. 9.Patients with a history of nonadherence with medications

Outcome results