Table 3.

Protocol Definition of a Pulmonary Exacerbation

The presence of a protocol-defined pulmonary exacerbation is defined by the following: One of the major criteria alone or Two of the minor signs/symptoms and fulfillment of symptom duration

Major Criteria: (One finding alone establishes the presence of a pulmonary exacerbation)

(1) Absolute decrease in FEV1 (L) of ≥ 10% from best baseline at study initiation using office spirometry, unresponsive to albuterol (in participants able to reproducibly perform spirometry)

(2)Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from previous baseline

(3) New lobar infiltrate(s) or atelectasi(e)s on chest radiograph

(4) Hemoptysis (more than streaks on more than one occasion in past week)

Minor Signs/Symptoms: (Two minor signs/symptoms are required with duration criteria in the absence of major criteria)

(1) Increased work of breathing or respiratory rate

(2) New or increased adventitial sounds on lung exam

(3) Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months

(4) Increased cough

(5) Decreased exercise tolerance or level of activity

(6) Increased chest congestion or change in sputum

Sign/Symptom Duration: (Required with two minor signs/symptoms in absence of major criteria): Initial sign or symptom present for ≥ 3 days

Duration of sign/symptoms ≥3 days