Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis (EPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097773
Recruitment Status : Completed
First Posted : December 1, 2004
Results First Posted : November 7, 2013
Last Update Posted : February 28, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Information provided by (Responsible Party):
Bonnie Ramsey, Seattle Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Cystic Fibrosis
Pulmonary Disease, Chronic Obstructive
Interventions Drug: Tobramycin solution for inhalation (TOBI)
Drug: Oral placebo
Drug: Oral ciprofloxacin
Enrollment 304
Recruitment Details Recruitment was conducted from December 2004 to June 2009 from 55 Cystic Fibrosis Foundation accredited clinical centers throughout the US
Pre-assignment Details  
Arm/Group Title Cycled TOBI and Oral Placebo Cycled TOBI and Oral Ciprofloxacin Culture-Based TOBI and Oral Ciprofloxacin Culture-Based TOBI and Oral Placebo
Hide Arm/Group Description Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa) Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
Period Title: Overall Study
Started 76 76 76 76
Completed 68 68 68 73
Not Completed 8 8 8 3
Reason Not Completed
Lost to Follow-up             2             2             0             1
Physician Decision             2             2             3             1
Withdrawal by Subject             3             3             3             1
Adverse Event             0             1             0             0
Other             1             0             2             0
Arm/Group Title Cycled TIS w/Placebo Cycled TIS w/Cipro Culture-Based TIS w/Placebo Culture-Based TIS w/Cipro Total
Hide Arm/Group Description TOBI and oral placebo for six consecutive quarterly cycles TOBI and oral ciprofloxacin for six consecutive quarterly cycles TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa) TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa) Total of all reporting groups
Overall Number of Baseline Participants 76 76 76 76 304
Hide Baseline Analysis Population Description
Intent to Treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 76 participants 76 participants 76 participants 304 participants
<=18 years
76
 100.0%
76
 100.0%
76
 100.0%
76
 100.0%
304
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 76 participants 76 participants 76 participants 304 participants
5.8  (3.43) 5.9  (3.28) 6.0  (3.74) 5.0  (3.58) 5.7  (3.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 76 participants 76 participants 76 participants 304 participants
Female
45
  59.2%
32
  42.1%
40
  52.6%
37
  48.7%
154
  50.7%
Male
31
  40.8%
44
  57.9%
36
  47.4%
39
  51.3%
150
  49.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 76 participants 76 participants 76 participants 304 participants
76 76 76 76 304
1.Primary Outcome
Title Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization
Hide Description

The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.

Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.

Time Frame Measured over the 18 month study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Cycled TIS Culture-Based TIS Oral Ciprofloxacin Oral Placebo
Hide Arm/Group Description:
Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
Pooled Culture-Based TIS therapy group
Pooled oral cipro group
Pooled oral placebo group
Overall Number of Participants Analyzed 152 152 152 152
Measure Type: Number
Unit of Measure: number of participants
24 26 29 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cycled TIS, Culture-Based TIS
Comments The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments There was no significant interaction with ciprofloxacin in this analysis.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.54 to 1.66
Estimation Comments risk of exacerbation comparing cycled therapy to culture-based therapy
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Ciprofloxacin, Oral Placebo
Comments A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.82 to 2.54
Estimation Comments risk of exacerbation comparing oral cipro to oral placebo
2.Secondary Outcome
Title Proportion of Participants With a Pa Positive Culture
Hide Description

Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152).

Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns

Time Frame Week 10 (after initial treatment course for Pa) through Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Cycled TIS Culture-Based TIS Oral Cipro Oral Placebo
Hide Arm/Group Description:
Pooled Cycled TIS group
Pooled Culture-Based TIS group
Pooled oral cipro group
pooled oral placebo group
Overall Number of Participants Analyzed 152 152 152 152
Measure Type: Number
Unit of Measure: Participants
No Pa positive cultures 109 85 97 97
1 Pa positive culture 17 38 22 33
2 Pa positive cultures 9 18 13 14
3 or more Pa positive cultures 13 9 14 8
Missing 4 2 6 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cycled TIS, Culture-Based TIS
Comments Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Logistic
Comments No interaction with ciprofloxacin usage was observed.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.78
Confidence Interval 95%
0.49 to 1.23
Estimation Comments odds of a positive culture comparing cycled therapy to culture-based therapy
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Cipro, Oral Placebo
Comments Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.71 to 1.71
Estimation Comments odds of a positive culture comparing the cipro group to the placebo group
3.Secondary Outcome
Title Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics
Hide Description

The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.

Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.

Time Frame Measured over the 18 month time period
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Cycled TIS Culture-Based TIS Oral Ciprofloxacin Oral Placebo
Hide Arm/Group Description:
Pooled Cycled TIS therapy group
Pooled Culture-Based TIS therapy group
Pooled oral cipro group
Pooled oral placebo group
Overall Number of Participants Analyzed 152 152 152 152
Measure Type: Number
Unit of Measure: participants
70 81 83 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cycled TIS, Culture-Based TIS
Comments The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Regression, Cox
Comments No interaction with ciprofloxacin usage was observed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.58 to 1.11
Estimation Comments Hazard ratio comparing cycled to culture based therapy
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Ciprofloxacin, Oral Placebo
Comments This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.94 to 1.78
Estimation Comments Hazard ratio comparing cipro to placebo.
Time Frame Randomization through Month 18
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cycled TIS w/Placebo Cycled TIS w/Cipro Culture-Based TIS w/Placebo Culture-Based TIS w/Cipro
Hide Arm/Group Description TOBI and oral placebo for six consecutive quarterly cycles TOBI and oral ciprofloxacin for six consecutive quarterly cycles TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA) TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
All-Cause Mortality
Cycled TIS w/Placebo Cycled TIS w/Cipro Culture-Based TIS w/Placebo Culture-Based TIS w/Cipro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cycled TIS w/Placebo Cycled TIS w/Cipro Culture-Based TIS w/Placebo Culture-Based TIS w/Cipro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/76 (23.68%)      21/76 (27.63%)      17/76 (22.37%)      27/76 (35.53%)    
Gastrointestinal disorders         
Abdominal Discomfort * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Abdominal Pain * 1  2/76 (2.63%)  2 1/76 (1.32%)  1 2/76 (2.63%)  2 0/76 (0.00%)  0
Colitis * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Constipation * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 3/76 (3.95%)  6
Distal Intestinal Obstruction Syndrome * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 1/76 (1.32%)  1 0/76 (0.00%)  0
Haematemesis * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Ileus * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Pancreatitis * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Vomiting * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
General disorders         
Chest Pain * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Fatigue * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Pyrexia * 1  0/76 (0.00%)  0 1/76 (1.32%)  2 2/76 (2.63%)  2 0/76 (0.00%)  0
Immune system disorders         
Drug Hypersensitivity * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Infections and infestations         
Acute Sinusitis * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Bronchiectasis * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Bronchopneumonia * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 1/76 (1.32%)  1
Lobar Pneumonia * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 1/76 (1.32%)  1 2/76 (2.63%)  2
Pneumonia * 1  1/76 (1.32%)  1 1/76 (1.32%)  1 1/76 (1.32%)  1 1/76 (1.32%)  1
Pseudomonas Infection * 1  2/76 (2.63%)  2 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Respiratory Syncytial Virus Infection * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Streptococcal Infection * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Injury, poisoning and procedural complications         
Head Injury * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Overdose * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Skull Fracture * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Investigations         
Blood Urine Present * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Body Temperature Increased * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Breath Sounds Abnormal * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Bronchoscopy * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Forced Expiratory Volume Decreased * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 4/76 (5.26%)  4 0/76 (0.00%)  0
Pulmonary Function Test Decreased * 1  3/76 (3.95%)  3 2/76 (2.63%)  3 1/76 (1.32%)  2 2/76 (2.63%)  3
Metabolism and nutrition disorders         
Dehydration * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Failure to Thrive * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 1/76 (1.32%)  1
Hypoglycaemia * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 2/76 (2.63%)  3
Back Pain * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung Neoplasm * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Nervous system disorders         
Convulsion * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Atelectasis * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 1/76 (1.32%)  1
Cough * 1  3/76 (3.95%)  4 5/76 (6.58%)  9 2/76 (2.63%)  2 5/76 (6.58%)  7
Dyspnoea * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Haemoptysis * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Lung Infiltration * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 1/76 (1.32%)  1 1/76 (1.32%)  1
Nasal Congestion * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Nasal Oedema * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Nasal Polyps * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Productive Cough * 1  0/76 (0.00%)  0 2/76 (2.63%)  2 0/76 (0.00%)  0 1/76 (1.32%)  1
Rales * 1  2/76 (2.63%)  2 1/76 (1.32%)  2 1/76 (1.32%)  1 1/76 (1.32%)  1
Respiratory Tract Congestion * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythema Nodosum * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Urticaria * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0
Surgical and medical procedures         
Adenotonsillectomy * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Central Venous Catheterisation * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
Gastrointestinal Tube Insertion * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Gastrostomy Tube Insertion * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Nasal Polypectomy * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Polypectomy * 1  1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Sinus Operation * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 2/76 (2.63%)  2 1/76 (1.32%)  1
Tonsillectomy * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 1/76 (1.32%)  1
Vesicoureteral Reflux Surgery * 1  0/76 (0.00%)  0 1/76 (1.32%)  1 0/76 (0.00%)  0 0/76 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cycled TIS w/Placebo Cycled TIS w/Cipro Culture-Based TIS w/Placebo Culture-Based TIS w/Cipro
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/76 (85.53%)      67/76 (88.16%)      65/76 (85.53%)      73/76 (96.05%)    
Blood and lymphatic system disorders         
Lymphadenopathy * 1  12/76 (15.79%)  13 8/76 (10.53%)  8 13/76 (17.11%)  14 11/76 (14.47%)  12
Ear and labyrinth disorders         
Ear Pain * 1  8/76 (10.53%)  13 9/76 (11.84%)  11 11/76 (14.47%)  18 17/76 (22.37%)  19
Middle Ear Effusion * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 6/76 (7.89%)  8
Tympanic Membrane Disorder * 1  6/76 (7.89%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Eye disorders         
Conjunctivitis * 1  0/76 (0.00%)  0 6/76 (7.89%)  6 10/76 (13.16%)  10 4/76 (5.26%)  5
Eye Discharge * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  8
Ocular Hyperaemia * 1  0/76 (0.00%)  0 4/76 (5.26%)  5 4/76 (5.26%)  4 0/76 (0.00%)  0
Gastrointestinal disorders         
Abdominal Discomfort * 1  7/76 (9.21%)  8 5/76 (6.58%)  8 4/76 (5.26%)  4 0/76 (0.00%)  0
Abdominal Distension * 1  4/76 (5.26%)  4 0/76 (0.00%)  0 4/76 (5.26%)  4 4/76 (5.26%)  7
Abdominal Pain * 1  17/76 (22.37%)  20 12/76 (15.79%)  15 16/76 (21.05%)  21 12/76 (15.79%)  15
Abdominal Pain Upper * 1  14/76 (18.42%)  22 18/76 (23.68%)  34 15/76 (19.74%)  35 17/76 (22.37%)  30
Constipation * 1  6/76 (7.89%)  8 9/76 (11.84%)  15 13/76 (17.11%)  14 11/76 (14.47%)  13
Diarrhoea * 1  15/76 (19.74%)  24 22/76 (28.95%)  40 22/76 (28.95%)  24 26/76 (34.21%)  49
Flatulence * 1  4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Frequent Bowel Movements * 1  4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  6
Malabsorption * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5
Nausea * 1  0/76 (0.00%)  0 12/76 (15.79%)  21 6/76 (7.89%)  7 7/76 (9.21%)  11
Oral Pain * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  6
Post-Tussive Vomiting * 1  5/76 (6.58%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Steatorrhoea * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  5
Teething * 1  4/76 (5.26%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5
Toothache * 1  0/76 (0.00%)  0 4/76 (5.26%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0
Vomiting * 1  29/76 (38.16%)  52 30/76 (39.47%)  52 35/76 (46.05%)  49 37/76 (48.68%)  70
General disorders         
Asthenia * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0
Chest Pain * 1  6/76 (7.89%)  8 7/76 (9.21%)  8 6/76 (7.89%)  8 11/76 (14.47%)  15
Chills * 1  0/76 (0.00%)  0 4/76 (5.26%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0
Crepitations * 1  0/76 (0.00%)  0 5/76 (6.58%)  6 0/76 (0.00%)  0 4/76 (5.26%)  4
Exercise Tolerance Decreased * 1  4/76 (5.26%)  4 6/76 (7.89%)  7 0/76 (0.00%)  0 0/76 (0.00%)  0
Fatigue * 1  11/76 (14.47%)  19 7/76 (9.21%)  9 13/76 (17.11%)  21 10/76 (13.16%)  14
Irritability * 1  4/76 (5.26%)  4 4/76 (5.26%)  5 0/76 (0.00%)  0 8/76 (10.53%)  11
Pain * 1  5/76 (6.58%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Pyrexia * 1  46/76 (60.53%)  85 45/76 (59.21%)  107 57/76 (75.00%)  138 57/76 (75.00%)  129
Immune system disorders         
Seasonal Allergy * 1  0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0
Infections and infestations         
Conjunctivitis Infective * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  5 0/76 (0.00%)  0
Ear Infection * 1  5/76 (6.58%)  6 12/76 (15.79%)  17 8/76 (10.53%)  8 17/76 (22.37%)  25
Influenza * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0
Nasopharyngitis * 1  4/76 (5.26%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  6
Otitis Media * 1  17/76 (22.37%)  24 7/76 (9.21%)  7 21/76 (27.63%)  33 15/76 (19.74%)  23
Pharyngitis Streptococcal * 1  7/76 (9.21%)  10 9/76 (11.84%)  11 6/76 (7.89%)  9 11/76 (14.47%)  16
Rhinitis * 1  7/76 (9.21%)  10 10/76 (13.16%)  12 10/76 (13.16%)  11 6/76 (7.89%)  11
Sinusitis * 1  13/76 (17.11%)  20 13/76 (17.11%)  15 11/76 (14.47%)  16 22/76 (28.95%)  25
Upper Respiratory Tract Infection * 1  0/76 (0.00%)  0 5/76 (6.58%)  6 0/76 (0.00%)  0 4/76 (5.26%)  4
Injury, poisoning and procedural complications         
Arthropod Bite * 1  5/76 (6.58%)  5 5/76 (6.58%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0
Contusion * 1  5/76 (6.58%)  5 5/76 (6.58%)  8 4/76 (5.26%)  5 6/76 (7.89%)  8
Excoriation * 1  4/76 (5.26%)  5 4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0
Procedural Pain * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Skin Laceration * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 7/76 (9.21%)  7
Sunburn * 1  0/76 (0.00%)  0 5/76 (6.58%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0
Investigations         
Alanine Aminotransferase Increased * 1  0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0
Aspartate Aminotransferase Increased * 1  0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0 0/76 (0.00%)  0
Breath Sounds Abnormal * 1  9/76 (11.84%)  13 10/76 (13.16%)  15 10/76 (13.16%)  13 8/76 (10.53%)  8
Chest X-Ray Abnormal * 1  8/76 (10.53%)  8 7/76 (9.21%)  9 9/76 (11.84%)  9 8/76 (10.53%)  9
Forced Expiratory Volume Decreased * 1  11/76 (14.47%)  16 12/76 (15.79%)  15 9/76 (11.84%)  10 9/76 (11.84%)  11
Increased Anteroposterior Chest Diameter * 1  4/76 (5.26%)  4 5/76 (6.58%)  5 4/76 (5.26%)  5 0/76 (0.00%)  0
Methicillin-Resistant Staphylococcal Aureus Test Positive * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Pulmonary Function Test Decreased * 1  4/76 (5.26%)  5 5/76 (6.58%)  6 5/76 (6.58%)  5 9/76 (11.84%)  14
Respiratory Rate Increased * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Sputum Abnormal * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0
Weight Decreased * 1  7/76 (9.21%)  9 10/76 (13.16%)  12 6/76 (7.89%)  6 14/76 (18.42%)  17
White Blood Cell Count Increased * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5
Metabolism and nutrition disorders         
Decreased Appetite * 1  17/76 (22.37%)  27 9/76 (11.84%)  10 9/76 (11.84%)  9 20/76 (26.32%)  30
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  14/76 (18.42%)  17 14/76 (18.42%)  25 14/76 (18.42%)  18 12/76 (15.79%)  14
Back Pain * 1  0/76 (0.00%)  0 7/76 (9.21%)  8 0/76 (0.00%)  0 5/76 (6.58%)  7
Clubbing * 1  7/76 (9.21%)  7 15/76 (19.74%)  16 7/76 (9.21%)  8 8/76 (10.53%)  9
Muscle Spasms * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  6 0/76 (0.00%)  0
Musculoskeletal Pain * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  7 0/76 (0.00%)  0
Myalgia * 1  4/76 (5.26%)  4 0/76 (0.00%)  0 6/76 (7.89%)  6 0/76 (0.00%)  0
Neck Pain * 1  0/76 (0.00%)  0 8/76 (10.53%)  8 0/76 (0.00%)  0 0/76 (0.00%)  0
Pain in Extremity * 1  7/76 (9.21%)  8 15/76 (19.74%)  27 10/76 (13.16%)  16 12/76 (15.79%)  14
Nervous system disorders         
Dizziness * 1  0/76 (0.00%)  0 5/76 (6.58%)  7 6/76 (7.89%)  6 4/76 (5.26%)  7
Headache * 1  38/76 (50.00%)  72 28/76 (36.84%)  69 24/76 (31.58%)  47 31/76 (40.79%)  75
Lethargy * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 6/76 (7.89%)  7
Psychiatric disorders         
Decreased Activity * 1  10/76 (13.16%)  11 5/76 (6.58%)  5 5/76 (6.58%)  5 7/76 (9.21%)  7
Renal and urinary disorders         
Dysuria * 1  4/76 (5.26%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Atelectasis * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5 0/76 (0.00%)  0
Bronchial Wall Thickening * 1  5/76 (6.58%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Cough * 1  62/76 (81.58%)  202 63/76 (82.89%)  240 65/76 (85.53%)  224 71/76 (93.42%)  282
Dysphonia * 1  11/76 (14.47%)  16 16/76 (21.05%)  28 12/76 (15.79%)  26 15/76 (19.74%)  22
Dyspnoea * 1  5/76 (6.58%)  6 8/76 (10.53%)  9 13/76 (17.11%)  19 7/76 (9.21%)  9
Epistaxis * 1  8/76 (10.53%)  9 7/76 (9.21%)  8 12/76 (15.79%)  20 8/76 (10.53%)  11
Nasal Congestion * 1  44/76 (57.89%)  88 38/76 (50.00%)  68 40/76 (52.63%)  85 48/76 (63.16%)  98
Nasal Discomfort * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4 0/76 (0.00%)  0
Nasal Mucosal Disorder * 1  6/76 (7.89%)  8 7/76 (9.21%)  9 10/76 (13.16%)  12 6/76 (7.89%)  6
Nasal Oedema * 1  8/76 (10.53%)  10 8/76 (10.53%)  9 9/76 (11.84%)  11 12/76 (15.79%)  13
Nasal Polyps * 1  4/76 (5.26%)  4 8/76 (10.53%)  9 9/76 (11.84%)  10 7/76 (9.21%)  7
Oropharyngeal Pain * 1  19/76 (25.00%)  31 26/76 (34.21%)  51 24/76 (31.58%)  36 28/76 (36.84%)  59
Pharyngeal Erythema * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4 5/76 (6.58%)  5
Postnasal Drip  1  0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5 0/76 (0.00%)  0
Productive Cough * 1  17/76 (22.37%)  23 23/76 (30.26%)  40 22/76 (28.95%)  38 28/76 (36.84%)  48
Rales * 1  10/76 (13.16%)  11 13/76 (17.11%)  19 11/76 (14.47%)  16 12/76 (15.79%)  16
Respiratory Tract Congestion * 1  7/76 (9.21%)  8 17/76 (22.37%)  32 13/76 (17.11%)  15 13/76 (17.11%)  18
Rhinorrhoea * 1  41/76 (53.95%)  100 48/76 (63.16%)  123 47/76 (61.84%)  119 50/76 (65.79%)  139
Rhonchi * 1  6/76 (7.89%)  6 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Sinus Congestion * 1  5/76 (6.58%)  7 6/76 (7.89%)  6 0/76 (0.00%)  0 5/76 (6.58%)  6
Sneezing * 1  5/76 (6.58%)  7 6/76 (7.89%)  6 0/76 (0.00%)  0 5/76 (6.58%)  6
Sputum Discolored * 1  0/76 (0.00%)  0 4/76 (5.26%)  8 4/76 (5.26%)  4 0/76 (0.00%)  0
Tachypnoea * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 4/76 (5.26%)  4
Tonsillar Hypertrophy * 1  9/76 (11.84%)  9 4/76 (5.26%)  4 7/76 (9.21%)  7 5/76 (6.58%)  6
Wheezing * 1  18/76 (23.68%)  24 15/76 (19.74%)  24 12/76 (15.79%)  16 17/76 (22.37%)  22
Skin and subcutaneous tissue disorders         
Dermatitis Contact * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 5/76 (6.58%)  5
Dermatitis Diaper * 1  0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0 10/76 (13.16%)  18
Erythema * 1  4/76 (5.26%)  4 0/76 (0.00%)  0 4/76 (5.26%)  7 0/76 (0.00%)  0
Rash * 1  11/76 (14.47%)  15 13/76 (17.11%)  18 16/76 (21.05%)  21 16/76 (21.05%)  19
Urticaria * 1  4/76 (5.26%)  5 0/76 (0.00%)  0 0/76 (0.00%)  0 0/76 (0.00%)  0
Surgical and medical procedures         
Sinus Operation * 1  0/76 (0.00%)  0 7/76 (9.21%)  7 0/76 (0.00%)  0 0/76 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bonnie Ramsey, MD
Organization: Seattle Childrens Hospital
Phone: 206-987-5725
EMail: bonnie.ramsey@seattlechildrens.org
Layout table for additonal information
Responsible Party: Bonnie Ramsey, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00097773     History of Changes
Other Study ID Numbers: 169
U01HL080310 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2004
First Posted: December 1, 2004
Results First Submitted: June 11, 2013
Results First Posted: November 7, 2013
Last Update Posted: February 28, 2014