Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00124709
• Collaborator: (none)
• Enrollment: 1,091
• Locations: 36
• Arms: 2
• Duration (Months): 61
• Patients Per Site: 30.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus; Drug: Corticosteroid	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1091 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus	Drug: Pimecrolimus; Pimecrolimus cream 1 %; Other Names: Elidel
Active Comparator: 2 Corticosteroid	Drug: Corticosteroid; conventional corticosteroid-based treatment

Outcome Measures

Primary Outcome Measures

1. Atopic Dermatitis (AD) Disease Control Over 36 Months [36 months]

   Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.

2. Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age [6 years]

   Note: The results for this efficacy variable are not reported due to early termination of the study.

Secondary Outcome Measures

1. Long Term Safety in Infants and Young Children [6 years]

   Note: The results of this secondary outcome is not reported due to early termination of the study.

2. Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies [6 years (36 month Double-Blind Phase)]

   Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study.

3. Corticosteroid and Pimecrolimus Drug Use [48 months]

   Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.

4. Atopic Dermatitis (AD) Remission Time [36 month Double-Blind Phase]

   Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".

5. Patient/Caregiver Quality of Life [From Baseline to Visit 5 , 6, 8, 10, 12, and 14]

   Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of atopic dermatitis

• Family history of atopy

• 3 to 18 months of age at baseline

• At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)

• Clinical evidence of atopic dermatitis for no longer than 3 months

Exclusion Criteria:

• Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Other protocol related criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Allergy and Asthma Center	Birmingham	Alabama	United States	35209
2	Northwest Arkansas Pediatric Clinic, P.A.	Fayetteville	Arkansas	United States	72703
3	The Children's Clinic of Jonesboro	Jonesboro	Arkansas	United States	72401
4	Southern California Research	Mission Viejo	California	United States	92691
5	Children's Hospital of Orange County	Orange	California	United States	92868
6	Stanford Dermatology Clinic and Clinical Trials Dept	Redwood City	California	United States	94063
7	Capital Allergy Respiratory Disease Center	Sacramento	California	United States	95819
8	Children's Hospital San Diego	San Diego	California	United States	92123
9	Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division	Walnut Creek	California	United States	94598
10	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
11	Dermatology Associates and Research	Coral Gables	Florida	United States	33134
12	Emerald Coast Clinical Research	Pensacola	Florida	United States	32503
13	Children's Memorial Hospital	Chicago	Illinois	United States	60614
14	Indiana University Outpatient Clinical Research	Indianapolis	Indiana	United States	46202
15	Central Kentucky Research Associates	Lexington	Kentucky	United States	40509
16	Dermatology Specialists	Louisville	Kentucky	United States	40202
17	Rx R & D	Metarie	Louisiana	United States	70002
18	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
19	Children's Hospital - Boston	Boston	Massachusetts	United States	02115
20	Dermatology, PLLC	Ann Arbor	Michigan	United States	48103
21	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
22	Central Dermatology	St Louis	Missouri	United States	63117
23	Skin Specialists, P.C.	Omaha	Nebraska	United States	68144
24	Dartmouth-Hitchcock Medical Center/Dermatology Section	Lebanon	New Hampshire	United States	03756
25	Children's Medical Group	Hopewell Junction	New York	United States	12533
26	Dermatology Associates of St. Luke's - Roosevelt	New York	New York	United States	10025
27	Calcagno Research and Development	Gresham	Oregon	United States	97030
28	Oregon Health Science University - Dermatology Dept.	Portland	Oregon	United States	97201
29	The Childrens' Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
30	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
31	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
32	Texas Children's Hospital, BCM	Houston	Texas	United States	77030
33	Alpine Medical Group, LLC	Salt Lake City	Utah	United States	84102
34	Granger Medical Clinic	West Valley City	Utah	United States	84120
35	Virginia Clinical Research	Norfolk	Virginia	United States	23507
36	Asthma Inc	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00124709
• Other Study ID Numbers: CASM981CUS09
• First Posted: Jul 28, 2005
• Last Update Posted: Mar 23, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Atopic, dermatitis, asthma, children, modification; Atopic dermatitis/atopy
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pimecrolimus

Study Results

Participant Flow

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Period Title: Overall Study
STARTED	546	545
Patients Who Received Study Medication	543	544
COMPLETED	291	273
NOT COMPLETED	255	272

Baseline Characteristics

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group	Total
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.	Total of all reporting groups
Overall Participants	543	544	1087
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	7.1 (3.76)	7.4 (4.06)	7.3 (3.91)
Age, Customized (Number) [Number]
Less than 3 months	1 0.2%	2 0.4%	3 0.3%
3 months to Less than 6 months	230 42.4%	223 41%	453 41.7%
6 months to Less than 12 months	231 42.5%	220 40.4%	451 41.5%
12 months to Less than or equal to 18 months	81 14.9%	99 18.2%	180 16.6%
Greater than 18 months	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	194 35.7%	218 40.1%	412 37.9%
Male	349 64.3%	326 59.9%	675 62.1%
Parents' Index of Quality of Life - Atopic Dermatitis Score (Scores on PIQoL-AD Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on PIQoL-AD Scale]	6.5 (4.73)	6.9 (4.92)	6.7 (4.83)

Outcome Measures

1. Primary Outcome

Title	Atopic Dermatitis (AD) Disease Control Over 36 Months
Description	Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Measure Participants	530	523
Mean (Standard Deviation) [Proportion of disease free days]	0.4404 (0.29876)	0.4346 (0.29317)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pimecrolimus (Elidel) Treatment Group, Control Treatment Group
	Comments	A disease-free day in Step 2 or less was defined as a diary day with variable "No or almost no eczema?"=yes and "medication used variable"=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7901
	Comments
	Method	ANCOVA
	Comments	Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0046
	Confidence Interval	(2-Sided) 95%; -0.0290 to 0.0381
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Description	Note: The results for this efficacy variable are not reported due to early termination of the study.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Long Term Safety in Infants and Young Children
Description	Note: The results of this secondary outcome is not reported due to early termination of the study.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Description	Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study.
Time Frame	6 years (36 month Double-Blind Phase)

Outcome Measure Data

Analysis Population Description

Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement.

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Measure Participants	533	532
Diagnosis of Food Allergy	16.1 3%	13.2 2.4%
Diagnosis of Allergic rhinitis	18.6 3.4%	16.4 3%
Diagnosis of Allergic conjunctivitis	12.4 2.3%	10.5 1.9%

5. Secondary Outcome

Title	Corticosteroid and Pimecrolimus Drug Use
Description	Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Safety population: all randomized patients who were dispensed study medication.

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Measure Participants	530	523
Double -blind phase	264.8 (259.49)	249.6 (251.71)
0-12 months (Year 1)	146.6 (105.75)	147.6 (112.69)
13-24 months (Year 2)	75.0 (105.08)	65.0 (97.42)
25-36 months (Year 3)	42.2 (83.65)	36.6 (76.31)
37-48 months (Year 4)	1.1 (5.74)	1.0 (5.34)

6. Secondary Outcome

Title	Atopic Dermatitis (AD) Remission Time
Description	Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".
Time Frame	36 month Double-Blind Phase

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Measure Participants	530	523
Mean (Standard Deviation) [Days]	105.9547 (137.61350)	117.1071 (150.33993)

7. Secondary Outcome

Title	Patient/Caregiver Quality of Life
Description	Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.
Time Frame	From Baseline to Visit 5 , 6, 8, 10, 12, and 14

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group	Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue	Management with vehicle/topical corticosteroid rescue.
Measure Participants	533	523
Change in Baseline to Visit 5 (Week 14)	-2.6 (3.67)	-2.3 (3.37)
Change in Baseline to Visit 6 (Week 27)	-2.7 (3.84)	-2.7 (3.83)
Change in Baseline to Visit 8 (Week 53)	-2.9 (3.97)	-3.1 (4.23)
Change in Baseline to Visit 10 (Week 88)	-3.1 (4.13)	-3.5 (4.23)
Change in Baseline to Visit 12 (Week 122)	-3.3 (4.15)	-3.6 (4.39)
Change in Baseline to Visit 14 (Week 158)	-3.5 (4.28)	-3.8 (4.35)

Adverse Events

Arm/Group Title	Pimecrolimus (Elidel) Treatment Group		Control Treatment Group
Arm/Group Description	Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue		Management with vehicle/topical corticosteroid rescue.
All Cause Mortality
	Pimecrolimus (Elidel) Treatment Group		Control Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pimecrolimus (Elidel) Treatment Group		Control Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/543 (7.7%)		37/544 (6.8%)
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura	1/543 (0.2%)		0/544 (0%)
Anemia	0/543 (0%)		1/544 (0.2%)
Congenital, familial and genetic disorders
Von Willebrand's disease	1/543 (0.2%)		0/544 (0%)
Eye disorders
Retinal hemorrhage	0/543 (0%)		1/544 (0.2%)
Gastrointestinal disorders
Intussusception	1/543 (0.2%)		0/544 (0%)
General disorders
Adverse drug reaction	0/543 (0%)		1/544 (0.2%)
Immune system disorders
Anaphylactic reaction	0/543 (0%)		2/544 (0.4%)
Food Allergy	0/543 (0%)		2/544 (0.4%)
Hypersensitivity	1/543 (0.2%)		0/544 (0%)
Milk allergy	0/543 (0%)		1/544 (0.2%)
Infections and infestations
Pneumonia	6/543 (1.1%)		6/544 (1.1%)
Gastroenteritis rotavirus	3/543 (0.6%)		4/544 (0.7%)
Bronchiolitis	2/543 (0.4%)		3/544 (0.6%)
Gastroenteritis	2/543 (0.4%)		2/544 (0.4%)
Respiratory syncytial virus infection	2/543 (0.4%)		2/544 (0.4%)
Respiratory syncytial virus bronchiolitis	2/543 (0.4%)		1/544 (0.2%)
Upper respiratory tract infection	2/543 (0.4%)		0/544 (0%)
Gastroenteritis viral	1/543 (0.2%)		1/544 (0.2%)
Pharyngitis	1/543 (0.2%)		1/544 (0.2%)
Pneumonia viral	1/543 (0.2%)		1/544 (0.2%)
Bronchitis	0/543 (0%)		2/544 (0.4%)
Adenovirus infection	1/543 (0.2%)		0/544 (0%)
Croup, infectious	1/543 (0.2%)		0/544 (0%)
Influenza	1/543 (0.2%)		0/544 (0%)
Lobar pneumonia	1/543 (0.2%)		0/544 (0%)
Lymph node abscess	1/543 (0.2%)		0/544 (0%)
Staphylococcal infection	1/543 (0.2%)		0/544 (0%)
Tonsillitis, streptococcal	1/543 (0.2%)		0/544 (0%)
Varicella	1/543 (0.2%)		0/544 (0%)
Abscess	0/543 (0%)		1/544 (0.2%)
Beta hemolytic streptococcal infection	0/543 (0%)		1/544 (0.2%)
Eczema, infected	0/543 (0%)		1/544 (0.2%)
Laryngotracheo bronchitis	0/543 (0%)		1/544 (0.2%)
Pneumonia, bacterial	0/543 (0%)		1/544 (0.2%)
Pyelonephritis	0/543 (0%)		1/544 (0.2%)
Rotavirus infection	0/543 (0%)		1/544 (0.2%)
Tonsillitis	0/543 (0%)		1/544 (0.2%)
Urinary tract infection	0/543 (0%)		1/544 (0.2%)
Injury, poisoning and procedural complications
Post procedural hemorrhage	1/543 (0.2%)		0/544 (0%)
Therapeutic agent toxicity	1/543 (0.2%)		0/544 (0%)
Femur fracture	0/543 (0%)		1/544 (0.2%)
Head injury	0/543 (0%)		1/544 (0.2%)
Hepatic trauma	0/543 (0%)		1/544 (0.2%)
Subdural hematoma	0/543 (0%)		1/544 (0.2%)
Metabolism and nutrition disorders
Dehydration	4/543 (0.7%)		5/544 (0.9%)
Failure to thrive	1/543 (0.2%)		0/544 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung	1/543 (0.2%)		0/544 (0%)
Nephroblastoma	1/543 (0.2%)		0/544 (0%)
Nervous system disorders
Febrile convulsions	2/543 (0.4%)		2/544 (0.4%)
Renal and urinary disorders
Hematuria	1/543 (0.2%)		0/544 (0%)
Reproductive system and breast disorders
Prepuce redundant	1/543 (0.2%)		0/544 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	7/543 (1.3%)		5/544 (0.9%)
Bronchial hyper-reactivity	3/543 (0.6%)		0/544 (0%)
Status asthmaticus	3/543 (0.6%)		0/544 (0%)
Wheezing	2/543 (0.4%)		1/544 (0.2%)
Bronchospasm	1/543 (0.2%)		1/544 (0.2%)
Respiratory distress	1/543 (0.2%)		1/544 (0.2%)
Acute respiratory distress syndrome	1/543 (0.2%)		0/544 (0%)
Dyspnea	1/543 (0.2%)		0/544 (0%)
Epiglottic edema	1/543 (0.2%)		0/544 (0%)
Hypoxia	1/543 (0.2%)		0/544 (0%)
Other (Not Including Serious) Adverse Events
	Pimecrolimus (Elidel) Treatment Group		Control Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	482/543 (88.8%)		467/544 (85.8%)
Eye disorders
Conjunctivitis, allergic	76/543 (14%)		63/544 (11.6%)
Conjunctivitis	50/543 (9.2%)		44/544 (8.1%)
Gastrointestinal disorders
Diarrhea	55/543 (10.1%)		46/544 (8.5%)
Teething	134/543 (24.7%)		135/544 (24.8%)
Vomiting	34/543 (6.3%)		29/544 (5.3%)
General disorders
Pyrexia	123/543 (22.7%)		123/544 (22.6%)
Immune system disorders
Food Allergy	140/543 (25.8%)		118/544 (21.7%)
Milk allergy	50/543 (9.2%)		35/544 (6.4%)
Infections and infestations
Upper Respiratory Tract Infection	288/543 (53%)		265/544 (48.7%)
Otitis Media	264/543 (48.6%)		260/544 (47.8%)
Nasopharyngitis	186/543 (34.3%)		175/544 (32.2%)
Gastroenteritis	76/543 (14%)		69/544 (12.7%)
Sinusitis	75/543 (13.8%)		61/544 (11.2%)
Gastroenteritis	55/543 (10.1%)		50/544 (9.2%)
Rhinitis	52/543 (9.6%)		49/544 (9%)
Croup infectious	46/543 (8.5%)		51/544 (9.4%)
Pharyngitis streptococcal	35/543 (6.4%)		55/544 (10.1%)
Pneumonia	45/543 (8.3%)		44/544 (8.1%)
Conjunctivitis, bacterial	39/543 (7.2%)		45/544 (8.3%)
Viral upper respiratory tract infection	37/543 (6.8%)		38/544 (7%)
Bronchitis	41/543 (7.6%)		30/544 (5.5%)
Bronchiolitis	28/543 (5.2%)		33/544 (6.1%)
Impetigo	22/543 (4.1%)		37/544 (6.8%)
Viral rash	29/543 (5.3%)		29/544 (5.3%)
Respiratory, thoracic and mediastinal disorders
Cough	187/543 (34.4%)		174/544 (32%)
Rhinitis allergic	122/543 (22.5%)		107/544 (19.7%)
Wheezing	102/543 (18.8%)		89/544 (16.4%)
Rhinorrhea	68/543 (12.5%)		63/544 (11.6%)
Asthma	64/543 (11.8%)		53/544 (9.7%)
Nasal Congestion	52/543 (9.6%)		43/544 (7.9%)
Skin and subcutaneous tissue disorders
Dermatitis diaper	44/543 (8.1%)		46/544 (8.5%)
Urticaria	41/543 (7.6%)		31/544 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.