Trial · NCT01316276
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (TEAEs) up to Day 672 | From Study Initiation up to Day 672 | Treatment emergent adverse events including serious adverse events (SAE) and adverse events (AE) leading to permanent discontinuation of study drug |
| Primary | Laboratory Abnormalities up to Day 672 | Baseline, Day 377 and Day 672 | * Number of Subjects with Grade 3 or Higher Abnormalities in Clinical Laboratory Values * Number of Subjects with Grade 3 or Higher Hematology Laboratory Value Abnormalities * Number of Subjects with Grade 3 or Higher Chemistry Laboratory Value Abnormalities |
| Primary | Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose | Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644 | Number of Subjects with a \>15% in Decline in Forced Expiratory Volume in 1 Second (FEV1) From Predose to Postdose |
| Primary | Respiratory Rate: Change From Baseline to Day 672 | From Study Initiation up to Day 672 | Respiratory rate was recorded at every visit as per standard practice at each investigational site. |
| Primary | Heart Rate: Change From Baseline From Day 672 | From Study Initiation up to Day 672 | Pulse rate (after at least 5-minute rest) was recorded at every visit as per standard practice at each investigational site. |
| Primary | Systolic BP: Change From Baseline at Day 672 | From Study Initiation up to Day 672 | Sitting blood pressure was recorded at every visit as per standard practice at each investigational site. |
| Primary | Diastolic BP: Change From Baseline at Day 672 | From Study Initiation up to Day 672 | Sitting blood pressure was recorded at every visit as per standard practice at each investigational site. |
| Primary | Body Temperature: Change From Baseline at Day 672 | From Study Initiation up to Day 672 | Body temperature was recorded at every visit as per standard practice at each investigational site. |
| Primary | Oxygen Saturation: Change From Baseline at Day 672 | From Study Initiation up to Day 672 | Change in oxygen saturation as measured with pulse oximetry was performed via finger probes placed on the extremity opposite arterial lines and noninvasive blood pressure monitoring devices so that pulsatile flow was not interrupted. |
| Primary | Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672 | Day 1, Day 169, Day 337, Day 505 and Day 672 | Sputum was cultured for quantitative microbiological evaluation of Pa and Burkholderia species in designated regional central microbiology laboratories. A standard microbiology protocol was used for Pa culture and identification for each morphologically distinct Pa phenotype. Although planned in the Statistical Analysis Plan (SAP), MICs of amikacin Burkholderia species were not determined due to the small number of isolates with Burkholderia. In addition, susceptibility testing of isolates of Pa and Burkholderia species against a panel of commonly used antipseudomonal antibiotics was planned but was not performed. The results of the following analyses for Pa isolates are presented. * Frequency of MIC of Amikacin * Frequency of MIC of Tobramycin MIC50: lowest concentration of the antibiotic at which 50 % of the isolates were inhibited. |
| Primary | Evaluation of Audiology | Day 337 and Day 672 | Hearing was evaluated using air conduction \[AC\]. Bone conduction was required if the AC testing demonstrated a decrease of \>20 decibels \[dB\]. Hearing loss was categorized using Common Terminology Criteria for Adverse Events as follows: GRADE 1 (best): Adults \[A\] on a Monitoring Program \[MP\]: Threshold shift of 15-25 dB; Pediatric \[P\]: Threshold shift \>20 dB at 8 kilohertz (kHz). GRADE 2: \[A\] on a MP: Threshold shift of \>25 dB; \[A\] not enrolled in MP: hearing loss; hearing aid/intervention not indicated; \[P\]: Threshold shift \>20 dB at 4 kHz and above. GRADE 3: \[A\] enrolled in MP: Threshold shift of \>25 dB; therapeutic intervention indicated; \[A\]: Not enrolled in MP: hearing aid/intervention; \[P\]: therapeutic intervention, including hearing aids: Threshold shift \>20 dB at 3 kHz and above; additional speech-language related services. GRADE 4 (worst): \[A\]: Profound bilateral hearing loss; non-serviceable hearing; \[P\]: cochlear implant \& additional speech-language related services. |
| Primary | Change in Serum Creatinine Throughout the Study | Baseline, Day 337 and Day 672 | * Common Terminology Criteria for Adverse Events (CTCAE) Grade 1: \> ULN-1.5 × ULN * CTCAE Grade 2: \> 1.5 × ULN to 3.0 x ULN |
| Secondary | Percent Change in FEV1 Throughout the Study | Baseline, Day 337 and Day 672 | Percent Change From Baseline in Predose FEV1 |
| Secondary | Number of Subjects Experiencing a Protocol Defined Pulmonary Exacerbation | From Study Initiation up to Day 700 | For number of subjects to first protocol-defined pulmonary exacerbation, follow-up time began at the first dose of study drug (Day 1) and ended no later than Day 700 (28-day follow up). |
| Secondary | Number of Subjects Initiating Treatment. | From Study Initiation up to Day 672 | The number of subjects initiating antipseudomonal therapy for protocol-defined pulmonary exacerbation confirmed by the investigator, and for investigator-defined pulmonary exacerbation were summarized. The data presented below is the Frequency of Systemic or Inhaled Antipseudomonal Therapy for Protocol-defined Pulmonary Exacerbations Confirmed by Investigator \- Time to First Use of Any New Antibiotic Treatment, Censoring at Date of Last Contact |
| Secondary | Number of Participants Who Received Antipseudomonal Antibiotic Treatment for Protocol Defined Pulmonary Exacerbation | From Study Initiation up to Day 700 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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