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Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine (KLARAINE)

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ClinicalTrials.gov Identifier: NCT01095978
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : June 15, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Condition Respiratory Tract Infections
Intervention Drug: Clarithromycin (Klacid SR)
Enrollment 2822
Recruitment Details  
Pre-assignment Details Of the 2822 participants enrolled, 22 were excluded from analysis for the following reasons: No baseline data (11), did not meet inclusion criteria (7), missing or inconsistent inclusion/final data (2), and no Klacid SR treatment (2). The per-protocol population consists of 2800 participants.
Arm/Group Title Klacid SR
Hide Arm/Group Description Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
Period Title: Overall Study
Started 2822
Completed 2819
Not Completed 3
Reason Not Completed
Did not take Klacid SR             2
Adverse Event             1
Arm/Group Title Klacid SR
Hide Arm/Group Description The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Overall Number of Baseline Participants 2800
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2800 participants
43.41  (13.79)
[1]
Measure Description: Based on the per-protocol population (2800 participants).
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2800 participants
18 to 20 years 64
21 to 34 years 763
35 to 64 years 1777
65 to 84 years 190
85 years or older 6
[1]
Measure Description: Based on the per-protocol population (2800 participants).
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Not reported Number Analyzed 2800 participants
2800
[1]
Measure Description: The gender of the participants was not collected in this study.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Ukraine Number Analyzed 2800 participants
2800
[1]
Measure Description: Based on the per-protocol population (2800 participants).
1.Primary Outcome
Title Body Temperature
Hide Description Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.
Time Frame Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Visit 1: No fever 183 170 13
Visit 1: Fever present 2617 2434 183
a) Fever resolved at Visit 2 1780 1655 125
b) Fever still present at Visit 2 837 779 58
2.Primary Outcome
Title Cough and Its Character
Hide Description Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.
Time Frame Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Visit 1: Did not have cough 118 110 8
Visit 2: Did not have cough 1813 1702 111
Visit 1: Had irritating cough 1671 1563 108
Visit 2: Had irritating cough 237 220 17
Visit 1: Had productive cough 1011 931 80
Visit 2: Had productive cough 749 682 67
Visit 1: Had both types of cough 0 0 0
Visit 2: Had both types of cough 1 0 1
Had any cough at Visit 1 and resolved at Visit 2 1712 1609 103
a) Irritating cough resolved at Visit 2 1438 1348 90
b) Productive cough resolved at Visit 2 274 261 13
3.Primary Outcome
Title Dyspnoea
Hide Description Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.
Time Frame Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Visit 1: No dyspnoea 1821 1753 68
Visit 2: No dyspnoea 2608 2451 157
Visit 1: Dyspnoea after exercise 883 766 117
Visit 2: Dyspnoea after exercise 181 143 38
Visit 1: Dyspnoea at rest 95 85 10
Visit 2: Dyspnoea at rest 1 1 0
Visit 1: Both types of dyspnoea 1 0 1
Visit 2: Both types of dyspnoea 10 9 1
Dyspnoea resolved at Visit 2 (either type) 799 710 89
a) After exercise dyspnoea resolved at Visit 2 705 626 79
b) Resting dyspnoea resolved at Visit 2 94 84 10
4.Primary Outcome
Title Auscultation Findings
Hide Description Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.
Time Frame Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Visit 1: Normal breath sounds 389 378 11
Visit 2: Normal breath sounds 2494 2350 144
Visit 1: Wheezing 1632 1518 114
Visit 2: Wheezing 184 153 31
Visit 1: Crackles 779 708 71
Visit 2: Crackles 122 101 21
Abnormal breath sounds resolved at Visit 2 2108 1974 134
a) Wheezing resolved at Visit 2 1449 1366 83
b) Crackles resolved at Visit 2 659 608 51
5.Primary Outcome
Title Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Hide Description Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.
Time Frame Visit 1 (Initial visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Findings did not indicate pneumonia 1742 1651 91
Findings indicated pneumonia 1058 953 105
6.Primary Outcome
Title Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)
Hide Description Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.
Time Frame Visit 1 (Initial visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Klacid SR given as first antibiotic 2381 2237 144
Klacid SR given as second antibiotic 377 327 50
Klacid SR given as third antibiotic 42 40 2
7.Primary Outcome
Title Therapeutic Response
Hide Description Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.
Time Frame Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total) Klacid SR (18 to 64 Years of Age) Klacid SR (65 Years of Age or Older)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Participants 18 to 64 years of age.
Participants 65 years of age or older.
Overall Number of Participants Analyzed 2800 2604 196
Measure Type: Number
Unit of Measure: Participants
Had therapeutic response to therapy 2786 2592 194
No therapeutic response to therapy 14 12 2
8.Secondary Outcome
Title Adverse Effects
Hide Description The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.
Time Frame Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Overall Number of Participants Analyzed 2800
Measure Type: Number
Unit of Measure: Participants
Non-serious adverse events (AEs) 14
Serious AEs 0
Discontinued due to AEs 1
Dose reduced or stopped temporarily due to AEs 0
9.Secondary Outcome
Title Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Hide Description Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.
Time Frame Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Overall Number of Participants Analyzed 2800
Measure Type: Number
Unit of Measure: Participants
Dosage was followed 2786
Dosage was not followed 14
a) Dosage not followed due to adverse event 1
b) Reason not reported 13
10.Secondary Outcome
Title Termination of Treatment
Hide Description The number of participants who discontinued treatment is summarized.
Time Frame Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population was analyzed.
Arm/Group Title Klacid SR (Total)
Hide Arm/Group Description:
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
Overall Number of Participants Analyzed 2800
Measure Type: Number
Unit of Measure: Participants
1
Time Frame Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Adverse Event Reporting Description The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
 
Arm/Group Title Klacid SR
Hide Arm/Group Description Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
All-Cause Mortality
Klacid SR
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Klacid SR
Affected / at Risk (%)
Total   0/2800 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Klacid SR
Affected / at Risk (%)
Total   14/2800 (0.50%) 
Gastrointestinal disorders   
Nausea * 1  7/2800 (0.25%) 
Abdominal pain upper * 1  3/2800 (0.11%) 
Disbacteriosis * 1  1/2800 (0.04%) 
Alanine aminotransferase increased * 1  1/2800 (0.04%) 
Aspartate aminotransferase increased * 1  1/2800 (0.04%) 
Diarrhoea * 1  1/2800 (0.04%) 
Dyspepsia * 1  1/2800 (0.04%) 
Nervous system disorders   
Dysgeusia * 1  6/2800 (0.21%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  1/2800 (0.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Layout table for additonal information
Responsible Party: Irina Magdik, Medical Director, Abbott Laboratories S.A., Ukraine
ClinicalTrials.gov Identifier: NCT01095978     History of Changes
Other Study ID Numbers: P11-979
First Submitted: February 28, 2010
First Posted: March 30, 2010
Results First Submitted: May 17, 2011
Results First Posted: June 15, 2011
Last Update Posted: July 11, 2011