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NCT00775138 · ClinicalTrials.gov registry record · Phase 2

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

A Phase 2 study of Bronchiectasis, sponsored by Insmed Incorporated.

Completed
Registry status
Phase 2
Development phase
64
Enrollment target
18
Study locations

NCT00775138: Completed Phase 2 study of Bronchiectasis, sponsored by Insmed Incorporated.

NCT00775138 is a Phase 2 study of Bronchiectasis that has completed, run by Insmed Incorporated. The registered enrollment target is 64 participants, below the 383-participant average among 13 other Bronchiectasis trials with a reported enrollment target (83% lower). The trial reports 18 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00775138, a Phase 2 study of Bronchiectasis, has completed, sponsored by Insmed Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
64 participants
Enrollment target
18
Study locations

Study Summary

This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

Primary Outcome

Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.

Conditions Studied

Bronchiectasis

Interventions

  • DRUG 280 mg Arikayce™
  • DRUG Matching Placebo for Cohort 1
  • DRUG 560 mg Arikayce™
  • DRUG Matching Placebo for Cohort 2

Study Locations (18)

Other

  • - Sofia
  • - Athens
  • - Mosdós
  • - Bangalore
  • - Hyderabad
  • - Manipal
  • - Mumbai
  • - Nagpur
  • - New Delhi
  • - Rabka-Zdrój
  • - Belgrade
  • - Kragujevac
  • - Niš
  • - Kiev
  • - Cambridge
  • - London

District of Columbia

  • - Washington D.C.

Pennsylvania

  • - Philadelphia

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2008-06-24
Est. Completion 2009-05-11
Phase Phase 2
Insmed Incorporated

31 total trials

What the finished NCT00775138 record still lists

NCT00775138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 383-participant average among 13 other Bronchiectasis trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Bronchiectasis appearing as the primary indexed condition, and to 4 interventions - of which 280 mg Arikayce™ is the first listed.

NCT00775138 lists 18 locations in 3 states (Other, District of Columbia, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT00775138 about?

NCT00775138 is a clinical study titled "Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.". This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

What is the current status of trial NCT00775138?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2008-06-24. Estimated completion is 2009-05-11.

What conditions does trial NCT00775138 study?

This clinical trial studies the following conditions: Bronchiectasis.

What interventions are being tested in trial NCT00775138?

The interventions under investigation include: 280 mg Arikayce™ (DRUG), Matching Placebo for Cohort 1 (DRUG), 560 mg Arikayce™ (DRUG), Matching Placebo for Cohort 2 (DRUG).

Who is sponsoring clinical trial NCT00775138?

This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00775138 being conducted?

This trial has 18 study locations across District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Bronchiectasis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00775138's enrollment target sits among peer trials

64 7th of 13 higher than 7 of 13 other Bronchiectasis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bronchiectasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00775138, the US trial registry maintained by the National Library of Medicine. NCT00775138 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.