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. 2016 Jan 27;2016(1):CD007525. doi: 10.1002/14651858.CD007525.pub3

Tamaoki 1992.

Methods Double‐blind, randomised, placebo‐controlled trial
Pulmonary function was assessed by a change in VC and FEV1 before treatment (day 0) and on day 14. Quality of life was assessed by the Borg ratio scale for questions related to breathlessness and dyspnoea
Sputum was analysed for change in production (g/day), cyclo‐oxygenase products (PGE2, PGF2a, 6‐oxo‐PGF1a, TxB2) and microbiological culture
Statistical analysis: data were expressed as means ± SEM. Two‐way analysis of variance and Student's paired t test were used for normally distributed variables. The Newman‐Keuls test was used for multiple comparisons. A P value less than 0.05 was considered statistically significant
Participants 25 adults (age 29 to 78 years) with a diagnosis of chronic lung disease (chronic bronchitis (N = 12), diffuse panbronchiolitis (N = 5) or bronchiectasis (N = 8)) and bronchorrhoea of at least 4 weeks. Eight of the 25 participants had bronchiectasis, but all had symptoms of bronchiectasis and 21 had chronic colonisation with respiratory pathogens present in the adults with bronchiectasis ‐ 17 had Pseudomonas aeruginosa, 3 Haemophilus influenzae and 1 Staphylococcus aureus. Of the 8 participants with bronchiectasis, 4 were allocated to the indomethacin group and 4 to the placebo group. All had no history of respiratory allergy
Interventions Treatment group 1: inhaled indomethacin, 2 mL aerosol preparation of 1.2 μg/mL in saline 3 times daily for 14 days
Treatment group 2: inhaled placebo, 2 mL aerosolised saline alone 3 times daily for 14 days
Method of delivery: nebuliser delivering aerosolised particles with a median particle diameter of 4.5 to 5 μm
Outcomes Data for all 3 disease states were analysed collectively. Outcomes were sputum indices (% solid composition, sputum bacterial density and inflammatory markers ‐ prostaglandin E2, PGF2a, 6‐oxo‐PGF1a, TxB2), Borg score ratio scale for breathlessness and dyspnoea, WCC, ESR and spirometry
The only outcome for which results were reported separately for participants with bronchiectasis was effect on sputum production
Notes We elected to include all outcomes, as although not all participants had the diagnosis of bronchiectasis, the additional 2 diseases (chronic bronchitis and panbronchiolitis) overlap with bronchiectasis and eventually can lead to bronchiectasis. Furthermore, the large number colonised with bacteria, especially with Pseudomonas, indicates that bronchiectasis would have been likely to be identified if a multi‐detector high‐resolution CT scan had been performed on all participants
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) High risk The doctor responsible for allocating treatment groups was not blinded but was not involved in follow‐up or data analysis
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Investigators responsible for disease follow‐up and data analysis were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data were complete for all outcomes
Selective reporting (reporting bias) Low risk We identified no selective reporting
Other bias Unclear risk We identified no other potential sources of bias. However, data analysis did not distinguish individuals with bronchiectasis from people with other respiratory disease

CT: computed tomography.
 ESR: erythrocyte sedimentation rate.
 FEV1: forced expiratory volume in one second.
 6‐oxo‐PGF1a: 6‐oxo‐prostaglandin F1 alpha.
 PGE2: prostaglandin E2.
 PGF2a: prostaglandin F2 alpha.
 SEM: standard error of the mean.
 TxB2: thromboxane B2.
 VC: vital capacity.
 WCC: white cell count.