Aquilina 2001.
| Methods | Single‐centre, double‐blind, parallel, placebo‐controlled RCT. Method of recruitment was not specified
Concomitant antitussives, mucolytics and beta‐2 agonist disallowed. Clinical evaluation performed on baseline, days 3, 7 and final. Participants assessed for signs and symptoms relevant to diagnosis of acute or chronic lung disease including sputum volume and characteristics, dyspnoea, cough, pulmonary auscultation, difficulty in expectorating Compliance not mentioned. Inclusion and exclusion criteria described in next column Description of withdrawals or drop‐outs not mentioned |
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| Participants | 14 participants allocated to neltenexine, 14 to placebo. 3 within group had pneumonia but data specific to pneumonia were unavailable Mean age of total group was 57.5 years (SD 3.04) Inclusion criteria: adults (aged > 18 years) with acute and chronic lung disease Exclusion criteria: pulmonary tuberculosis, lung cancer, allergy to neltenexine, severe bronchospasm (requiring beta‐2 agonist, corticosteroids or aminophylline), or pregnant or lactating women | |
| Interventions | Neltenexine (a mucolytic), 37.4 mg tds or placebo (1 tablet tds) for 10 to 12 days | |
| Outcomes | Overall physicians' assessment of efficacy scored: excellent, good, moderate, not satisfactory. Exact quantification unspecified Sputum volume, sputum characteristics (1 = serous to 5 = very purulent), and 5‐point scores for dyspnoea, cough, pulmonary auscultation, difficulty in expectorating, from 0 (absent) to 4 very severe | |
| Notes | Wrote to authors with no response Data for pneumonia alone not available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not specified |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo used |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐outs unclear |
| Selective reporting (reporting bias) | Unclear risk | Data for pneumonia alone could not be extracted |
| Other bias | Unclear risk | Data for pneumonia alone could not be extracted. Single‐centre study; further information sought from trial authors with no response |