Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ciprofloxacin for Inhalation 100 mg/day by inhalation |
|
| 2 | Experimental | Ciprofloxacin for inhalation 150 mg/day by inhalation |
|
| Placebo | Placebo Comparator | Placebo by inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin for Inhalation | Drug | 100 mg once daily by inhalation for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological efficacy | 28 days | |
| Time to, number of, severity of, and time to resolve exacerbations | 28 days | |
| Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
Have a diagnosis of cystic fibrosis..
Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
Have received an investigational drug or device within 28 days prior to Visit 1.
Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Bruinenberg, MBChB, MBA | Aradigm Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Ciprofloxacin for Inhalation |
| Drug |
150 mg once daily by inhalation for 28 days |
|
| Placebo | Drug | Placebo once daily by inhalation for 28 days |
|
| 28 days |
| Quality of life (QOL) | 28 days |
| Safety and tolerability | 28 days |
| Los Angeles |
| California |
| 90048 |
| United States |
| Sacramento | California | 95819 | United States |
| Torrance | California | 90505 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Brandon | Florida | 33511 | United States |
| Miami | Florida | 33136 | United States |
| Council Bluffs | Iowa | 51503 | United States |
| Summit | New Jersey | 07901 | United States |
| New York | New York | 10016 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Toledo | Ohio | 43614 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| McKinney | Texas | 75069 | United States |
| Calgary | Alberta | T2N 1L9 | Canada |
| Kelowna | British Columbia | V1Y 1E4 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V5Z 4E1 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Berlin | 13353 | Germany |
| Donaustauf | 93093 | Germany |
| Heidelberg | 69126 | Germany |
| Neuwied | 56564 | Germany |
| "Ground Floor, Tower Block, Lisburn Road | Belfast | Britain | BT9 7AB | United Kingdom |
| "1st Floor, Nuffield House, B15 2TH | Birmingham | Britain | United Kingdom |
| "Duckworth Lane, | Bradford | Britain | BD9 6RJ | United Kingdom |
| "Southmoor Road, M23 9LT | Manchester | Britain | United Kingdom |
| Newcastle upon Tyne | Freeman Road, High Heaton | NE7 7DN | United Kingdom |
| London | High Street Lewisham | SE13 6LH | United Kingdom |
| "Bordesley Green East | Birmingham | B9 5SS | United Kingdom |
| "133 Balornock Road | Glasgow | G21 3UW | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| "Stott Lane | Salford | M6 8HD | United Kingdom |
| "Newcastle Road | Stoke-on-Trent | ST4 6QG | United Kingdom |
| "Northumbria Healthcare | Tyne and Wear | NE29 8NH | United Kingdom |
| ID | Term |
|---|---|
| D011552 | Pseudomonas Infections |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided