Study protocol, rationale and recruitment in a European multi-centre randomized controlled trial to determine the efficacy and safety of azithromycin maintenance therapy for 6 months in primary ciliary dyskinesia

Table 3 Reasons for recruitment issues

Major reasons for refusal of participation:
Due to patients’ views:
	- Long travel distance to trial site.
	- Time consuming (e.g. not possible to take time off work).
	- Fear of adverse reactions.
	- Treatment burden.
	- Not perceiving themselves/their child as being ill and therefore finding medical maintenance therapy unnecessary.
	- Not seeing any personal gain in taking part in the research.
	- Already on maintenance antibiotics and not willing to discontinue this treatment.
	- Fear of blood sampling.
Due to eligibility criteria in study protocol:
	- Chronic Pseudomonas aeruginosa infection.
	- Systemic or inhaled maintenance antibiotics due to intermittent Pseudomonas aeruginosa infection or patient’s clinical status, which is not considered appropriate to discontinue.
	- Prohibited concomitant medication e.g. antidepressants.
	- Age outside the age range.

ISSN: 1471-2466