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Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease

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: NCT02730793
Recruitment Status : Terminated (terminated due to an inability to recruit study subjects)
First Posted : April 6, 2016
Results First Posted : January 12, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Eastern Virginia Medical School
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: Oral Aztreonam
Drug: Nasal Aztreonam
Drug: Nasal Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Period Title: Overall Study
Started 2 3
Completed 2 1
Not Completed 0 2
Reason Not Completed
Physician Decision             0             1
Withdrawal by Subject             0             1
Arm/Group Title Standard Therapy Study Therapy Total
Hide Arm/Group Description

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Number of Protocol-defined Pulmonary Exacerbations Treated With IV Anti-pseudomonal Antibiotics on Day 140
Hide Description Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with IV antibiotics will be determined from the medical record during the course of this study.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to First Protocol-defined Pulmonary Exacerbation Treated With IV Anti-pseudomonal Antibiotics
Hide Description Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with IV antibiotics will be determined from the medical record during the course of this study. The time of beginning the study to first protocol-defined pulmonary exacerbation will also be determined from the medical record during the course of this study.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Sinus and Nasal QoL Questionnaire (SNOT-20) on Day 140 and Day 168
Hide Description The Sino-Nasal Outcome Test 20 (SNOT-20) is a validated health-related QOL questionnarie designed to determine the impact of sinonasal dysfunction. Patients will assess nasal symptoms, emotion, and activity on a scale of worsening symptoms scored 1 through 7 to provide a quantifiable score capable of disease severity. It has been shown as a responsive measure of health-related quality of life and suitable for use in outcomes studies and routine clinical care. Survey responses from Day 140 and Day 168 will be compared to the SNOT20 survey responses from previous visits (V1, V2, and V4)
Time Frame Day 140 and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Cystic Fibrosis QoL Score (CFQ-R) on Day 140
Hide Description The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Visits 1, 6, and 7. The endpoint was change in CFQR on day 140 compared to V1 and V5.
Time Frame Day 140
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Pulmonary Function (FVC and FEV1 Percent Predicted) on Day 140
Hide Description Routine spirometry will be performed according to American Thoracic Society (ATS) guidelines. A minimum of three maneuvers will be performed. The largest FVC and FEV1 will be reported after examining data from all acceptable curves even if they did not originate from the same maneuver. Data will be expressed both in absolute values and as percent (%) predicted based upon NHANES predicted values.
Time Frame Day 140
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Paired Sputum Cultures and Nasal Swabs for Bacteria and Antibiotic Resistance
Hide Description Expectorated sputum and nasal swabs will be cultured at each visit using standardized procedures to identify CF pathogens as well as susceptibility to a standard panel of antibiotics.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Acoustic Rhinometry for Nasal Obstruction (Volume) (Will be Measured at VCU Site ).
Hide Description Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume. Reflected sound waves are painlessly introduced through nasal adaptors into the nasal passages allowing the production of area-distance graphs.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Safety and Adverse Events Including Nasal Stuffiness, Epistaxis, and Headache.
Hide Description The frequency, severity and duration of all nasal and pulmonary adverse events, regardless of cause, will be recorded in REDCap as an electronic case report form. Serious adverse events will be captured in OnCore. The frequency and severity of adverse events will be calculated for each patient, with each patient counted once using the most severe grade experienced. The duration of adverse events will be calculated by the number of days each event persisted. Tables will be generated for all adverse events including serious adverse events and withdraws from the study.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Protocol-defined Pulmonary Exacerbations Treated With Oral Anti-pseudomonal Antibiotics
Hide Description Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with oral antibiotics will be determined from the medical record during the course of this study.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description:

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Therapy Study Therapy
Hide Arm/Group Description

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Nasal Placebo-Normal Saline twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Placebo: Placebo (nasal saline twice per day)

Oral Inhalation via PARI Altera Device: Standard Therapy Comparator (Oral Aztreonam 75mg three times a day) AND Nasal Inhalation via PARI PAS Device: Experimental- Nasal Aztreonam 75 mg twice per day

Oral Aztreonam: Standard Therapy Comparator (Oral Cayston 75mg three times a day)

Nasal Aztreonam: Study Therapy (nasal Aztreonam 75mg twice per day)

All-Cause Mortality
Standard Therapy Study Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Standard Therapy Study Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Therapy Study Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruce K. Rubin MEngr, MD, MBA, FRCPC
Organization: Virginia Commonwealth University
Phone: 804 828 9604
EMail: bruce.rubin@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02730793    
Other Study ID Numbers: HM20005657
First Submitted: November 3, 2015
First Posted: April 6, 2016
Results First Submitted: December 17, 2020
Results First Posted: January 12, 2021
Last Update Posted: January 28, 2021