Skip to main content
. 2006 Sep 14;175(3):228–234. doi: 10.1164/rccm.200601-112OC

TABLE 1.

TREATMENT FAILURE CRITERIA

In-clinic measures
  • Prebronchodilator FEV1 values on two consecutive sets of spirometric determinations that are ⩽ 80% of that obtained at randomization

  • Post-bronchodilator FEV1 value that is ⩽ 80% of that obtained at randomization

At-home measures
  • Prebronchodilator PEF ⩽ 65% of baseline* on any two of three consecutive scheduled measurements*

  • Post-bronchodilator PEF ⩽ 80% of baseline

  • An increase in as-needed albuterol use of ⩾ 8 puffs per 24 h over baseline use for a period of 48 h, or ⩾ 16 puffs/24 h for 48 h

  • Either PEF ⩽ 65% of baseline or persistent asthma symptoms despite 60 min of repeated rescue β-agonist use

Additional criteria
  • Use of oral, parenteral, or non–study-related inhaled corticosteroids related to the treatment of worsened asthma

  • Emergency department therapy resulting in the use of corticosteroid therapy related to the treatment of worsened asthma

  • Physician clinical judgment for safety reasons

*

PEF rate measurements were scheduled on awakening (before bronchodilator use) and between 8 and 11 p.m.

Baseline values defined by the average daily measurement obtained during Weeks 3 and 4 of the run-in period.

Subjects meeting these criteria were also designated as experiencing an asthma exacerbation.