NCT00852579

Brief Summary

Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Mar 2009

Typical duration for phase_3 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

2.4 years

First QC Date

February 26, 2009

Last Update Submit

October 18, 2011

Conditions

Asthma

Keywords

AsthmaSmokerMacrolide

Outcome Measures

Primary Outcomes (1)

  • Peak expiratory flow rate.

    12 weeks

Secondary Outcomes (9)

  • Spirometry

    12 weeks

  • Asthma control score

    12 weeks

  • Average of last 7 days PEF measurements

    12 weeks

  • Sputum cell counts

    12 weeks

  • Fraction of expired nitric oxide

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Active treatment.

Drug: Azithromycin

2

PLACEBO COMPARATOR

Placebo control group.

Drug: Placebo

Interventions

AzithromycinDRUG

Daily dose 250mg

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma
  • Age 18-70
  • Current smoker
  • Duration of symptoms \>1yr with stability for 4 weeks
  • Able to maintain asthma without exacerbations during run in period
  • Able to wean off other asthma medication

You may not qualify if:

  • Ex-smokers or never smokers
  • Planning to quit smoking during duration of trial
  • Patients with unstable asthma
  • Patients with current epilepsy, psychosis or history of significant atrial or ventricular tachyarrhythmia
  • Corrected QT-interval greater than 450msec in women, 430msec in men
  • Low potassium levels. If can be corrected then screening can continue with confirmation of normal levels prior to taking study medication
  • Liver disease (ALT and/or AST levels 2 or more times ULN)
  • Significant renal disease (Creatinine or urea levels 2 or more times ULN)
  • Any previous severe adverse reactions to macrolides
  • Patients who are known to have specific IgE sensitivity or skin test positivity to grass pollen and a history of worsening of asthma due to hay fever will not be recruited from mid May to the end of July
  • Upper or lower respiratory tract infection in the 4 weeks prior to randomisation. Run in period can be prolonged in this situation to have 4 weeks with no respiratory infection prior to randomisation.
  • Patients who require medications known to interact with azithromycin
  • On other immunosuppressants or chronic antibiotics
  • Weight less than 45kg
  • Frequent asthma exacerbations (greater than 4) requiring oral corticosteroids in the year prior to randomisation
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, KA2 0BE, United Kingdom

Location

Related Publications (3)

  • Thomson NC, Chaudhuri R, Livingston E. Asthma and cigarette smoking. Eur Respir J. 2004 Nov;24(5):822-33. doi: 10.1183/09031936.04.00039004.

    PMID: 15516679BACKGROUND

  • Richeldi L, Ferrara G, Fabbri LM, Lasserson TJ, Gibson PG. Macrolides for chronic asthma. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002997. doi: 10.1002/14651858.CD002997.pub3.

    PMID: 16235309BACKGROUND

  • Cameron EJ, Chaudhuri R, Mair F, McSharry C, Greenlaw N, Weir CJ, Jolly L, Donnelly I, Gallacher K, Morrison D, Spears M, Evans TJ, Anderson K, Thomson NC. Randomised controlled trial of azithromycin in smokers with asthma. Eur Respir J. 2013 Nov;42(5):1412-5. doi: 10.1183/09031936.00093913. Epub 2013 Sep 13. No abstract available.

    PMID: 24036246DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Neil C Thomson, FRCP

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow - Respiratory Medicine

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

GB(2)