- Removal of the nasal spray aerosol type only. - Removal Single-blind single-blind NASACORT AQ placebo, which was planned at baseline. - Removal of stratification by age grouping. - Removal of randomization procedure, including Interactive voice response system. - Removal of statistical methods, including subset analyses. - Removal of the NASACORT AQ HFA Nasal Aerosol reference materials.

- Limiting the inclusion age to 3 years of age and older. - Clarifying why mild asthma is an inclusion criterion. - Excluding children with a bone age which is different from chronological age by more than 1 year. - Withholding intranasal corticosteroids and high potency topical corticosteroids for at least 6 weeks prior to baseline assessments. - Performing an additional physical examination and Tanner staging at the final follow-up visit (Visit 11). - Use of the 12-hour urinary free cortisol and not the urinary free cortisol corrected for creatinine to assess the effect of treatment on hypothalamic-pituitary-adrenal (HPA) axis. - Repeating the PAR symptoms assessment at the end of treatment, in addition to the proposed 14-day assessment prior to randomization. - Additional analyses to be included: A subset analysis excluding any subject who exhibits >Tanner Stage 2 characteristics at the end of treatment period; An analysis of the percent of children who are below a certain percentile of growth velocity (eg, 3 rd percentile) or percent of children whose percentile of height decreases during the treatment period; A subset analysis excluding children who receive systemic corticosteroids during the double-blind treatment period. - A statistical analysis adjusting for the age factor in order to prevent variation between strata that could contribute to variation in the treatment effect. - A linear regression model as it is a better method to estimate growth velocity since it takes into account all height measurements during the treatment period (vs change from baseline in height where it does not). - Removal CLARITIN Reditabs as a rescue medication option.

Corrections in typographical errors and clarification of the timing of the dose.

- An administrative change in responsible medical expert and sponsor signatory. - A change in the protocol title to extend the age range from 3-8 to 3-9 (9 year old males only). - A correction in the study duration and dates. - Re-wording of the Primary and Secondary Objectives; Inclusion and Exclusion Criteria; Concomitant Treatments section for greater clarity - A change in the Study Design to remove the Single-Blind Run-In period and insert the use of demo placebo prior to randomization at Visit 3 - A change in Urinary Cortisol from 12 hour to 24 hour along with insertion of cortisol/creatinine ratio assessment in addition to urinary free cortisol; and insertion of normal ranges. - A change in the Treatments section to add demo placebo and greater detail regarding the use of the rescue medication, Claritin Syrup. - A change in study schedule at Visit 2 from -2 wks to -3 weeks to allow 1 week in which to complete the 24 urine collection and to ensure results are available to site prior to Visit 3, Randomization; also inserted early term visit procedures. - The Period of Observation extended to the time the last 24 hour urine specimen is returned after the final visit (V11 or Early Term Visit). - Inclusion of the revised NASACORT AQ package insert. - Deletion of the Appendices for the US NCHS Growth charts for boys and girls-5th to 95th percentiles, as only the 3rd to 97th percentile growth charts were to be used.

- Correction in staff location and nonfunctional hyperlinks. - Acceptance of an alternative bone image for bone assessment. - Modification of the inclusion criterion for rhinitis symptom score. - Demonstration of the placebo actuator earlier. - Adjustment of rescue medication use per manufacturer’s instructions. - Inclusion of a compliance measurement of partial dose administration. - Restriction of wearing shoes, socks, or head cover during height and weight measurements and allow a subject to wear light clothing or gown during height and weight measurements - Clarification that subject-reported daily diaries were to be dispensed at Visit 1 and collected, reviewed, and dispensed at Visits 2, 11, and early withdrawal Clarification of when subjects might prematurely be withdrawn - Administration of the first dose at the site - Clarification that subjects who become toilet trained after Visit 2 and did not complete the Visit 2 urine collection would not participate in the 24-hour urine collection procedure - Clarification that subjects who may have an abnormal cortisol at Visit 11 or an early withdrawal visit should either be continued for follow- up or referred to another physician – with documentation in the case report form - Permit the investigator or their designee to assess the validity of the 24-hour urine specimen - Define overdose by the sponsor - Permission of breaking of the blind by the investigator for expedited reporting or emergency medical treatment that would result in subject withdrawal.

- Changed Visit 10 study day from 365 ± 5 to 360 ± 5 days after Visit 3. - Deletion of bone age Inclusion and Exclusion criteria at Visit 2. - Removal of bone age assessment from the protocol. - Addition of Inclusion criterion: subjects must be toilet-trained. - Addition of exclusion criterion: abnormal 24-hour urinary free cortisol level. - Clarification of Upper Respiratory Tract Infection, sinus infection, or nasal candidiasis. - Clarification of inclusion criterion to specify “legal guardian” and to require subjects 7 years of age and older to provide a signed assent form. - Changed the expected duration of the study from 44 months to 56 months, and the end of subject recruitment from 1st quarter 2009 to 1st quarter 2010. - Provided instructions regarding the labeling of each bottle of the investigational product and instructions to subjects and caregivers. - Provided compliance rate calculation and dosing adherence post-randomization. - Deletion of exclusion criterion regarding concomitant use of nasal or oral antihistamine or decongestant or oral leukotriene modifier prior to Visit 3. - Expanded visit window for screening (Visit 1) and baseline (Visit 2). - Added permission to allow non-randomized subject to be re-screened and re-entered into the study. - Clarification of sample size calculation. - Broadening the definition of ITT population to include all subjects who received at least 1 dose of investigational product, regardless of their randomization status. - Clarification of the End of Study follow-up period. - Changed “Early Withdrawal” to “Early Termination”. - Clarification that End of Study (Follow-up/post-treatment) Visit 11 procedures should be completed at 60 ± 5 days after Visit 10 or an Early Termination visit. - Changed the 6-month visit date from 182 ± 5 days to 180 days ± 5 days and 12-month visit date from 365 ± 5 days to 360 ± 5 days. - Changed language to clarify stratification by age and sex.

- Expansion the number of clinical sites (from 60 to 100). - Clarification of systemic corticosteroid exclusion criterion: Treatment with systemic corticosteroids >2 courses received up to 1 year before Visit 1 was exclusionary. Up to 2 courses of systemic corticosteroids, each course not exceeding 14 days, up to 1 year before Visit 1 was allowed.

- Conduct the primary analysis in the mITT population. - Conduct sensitivity analyses in the intent-to-treat (ITT) and per-protocol (PP) populations and other defined analysis sets. - Define an mITT and PP population(s). - Broaden the desired precision for growth velocity to a total width of 2*0.45 cm/year. - Recalculate the sample size based on the desired precision . - Identify unusual individual growth velocities and discuss their impact on the results of the overall analysis of growth velocity in the clinical study report. - Perform statistical analyses that exclude questionable height measurements and include the percent of subjects who are below certain percentiles of growth velocity. - Perform descriptive statistics (comparison) on the growth velocities by sex and ethnicity. - Summarize the number of subjects at each visit (from screening to follow-up) by investigational product treatment group. - Conduct sensitivity analysis using the random-effects model accounting for repeated height measurements within subjects and for the difference in variance of the estimated individual growth slopes when the number of height measurements per subject varies across subjects