An unanticipated effect of clinical trial registration
Based on positive pilot results [1] we are currently enrolling
patients into a nationwide (US) practice-based research network (PBRN)
trial of the effectiveness of azithromycin as adjunctive treatment for
adult asthma (AZMATICS: www.clinicaltrials.gov/NCT 00266851). The
original protocol anticipated enrolling patients from the participating
PBRN practices, whereas we have now enrolled additional eligible subjects
who contacted the principal investigator (PI) after having searched the
clinicaltrials.gov website for asthma studies. A second unanticipated
source of subjects has been www.asthmastory.com, a website giving a
patient testimonial of a dramatic response to azithromycin treatment.
According to a non-systematic query from the PI, both websites could be
accessed from Google searches using such terms as “cure” and “asthma.”
Several patients, particularly those exposed to the compelling story
related on the latter website, have declined randomization in favor of
receipt of open-label treatment from the personal physician. We have
therefore added an observational arm to AZMATICS for this group that we
suspect have more severe asthma and a greater likelihood of response. For
our trial, patient self-referral via Internet has been an unanticipated
resource for study recruitment.
1. Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a
pilot randomized trial of azithromycin treatment for asthma. PLoS Clin
Trials 2006;1(2):e11 DOI: 10.1371/journal.pctr0010011.
Rapid Response:
An unanticipated effect of clinical trial registration
Based on positive pilot results [1] we are currently enrolling
patients into a nationwide (US) practice-based research network (PBRN)
trial of the effectiveness of azithromycin as adjunctive treatment for
adult asthma (AZMATICS: www.clinicaltrials.gov/NCT 00266851). The
original protocol anticipated enrolling patients from the participating
PBRN practices, whereas we have now enrolled additional eligible subjects
who contacted the principal investigator (PI) after having searched the
clinicaltrials.gov website for asthma studies. A second unanticipated
source of subjects has been www.asthmastory.com, a website giving a
patient testimonial of a dramatic response to azithromycin treatment.
According to a non-systematic query from the PI, both websites could be
accessed from Google searches using such terms as “cure” and “asthma.”
Several patients, particularly those exposed to the compelling story
related on the latter website, have declined randomization in favor of
receipt of open-label treatment from the personal physician. We have
therefore added an observational arm to AZMATICS for this group that we
suspect have more severe asthma and a greater likelihood of response. For
our trial, patient self-referral via Internet has been an unanticipated
resource for study recruitment.
1. Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a
pilot randomized trial of azithromycin treatment for asthma. PLoS Clin
Trials 2006;1(2):e11 DOI: 10.1371/journal.pctr0010011.
Competing interests:
None declared
Competing interests: No competing interests