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Trial record 12 of 17 for:    insmed

Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT03218917
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Brief Summary:
The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in patients with non-cystic fibrosis bronchiectasis.

Condition or disease Intervention/treatment Phase
Non-Cystic Fibrosis Bronchiectasis Drug: INS1007 10 mg oral tablet Drug: INS1007 25 mg oral tablet Drug: Placebo Oral Tablet Phase 2

Detailed Description:
Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: INS1007 10 mg Oral Tablet
Once per day for 24 weeks.
Drug: INS1007 10 mg oral tablet
Administered once per day for 24 weeks

Experimental: INS1007 25 mg Oral Tablet
Once per day for 24 weeks.
Drug: INS1007 25 mg oral tablet
Administered once per day for 24 weeks

Placebo Comparator: Placebo Oral Tablet
Once per day for 24 weeks.
Drug: Placebo Oral Tablet
Administered once per day for 24 weeks




Primary Outcome Measures :
  1. Time to first pulmonary exacerbation [ Time Frame: 24-week treatment period ]
    Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics.


Secondary Outcome Measures :
  1. Rate of pulmonary exacerbations [ Time Frame: 24-week treatment period ]
    Number of events per person-time over 24-weeks.

  2. Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire [ Time Frame: 24-week treatment period ]
    Change from Baseline symptom score at 24-weeks.

  3. Change from Screening in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: 24-week treatment period ]
    Change from Screening in FEV1 at 24-weeks.

  4. Change in concentration of active neutrophil elastase (NE) in sputum from pre-treatment to on treatment [ Time Frame: 24-week treatment period ]
    Change in concentration of active NE in sputum from pretreatment defined as as the average of Screening and Day 1 concentrations) to on-treatment (defined as the average of Week 12 and Week 24 concentrations).


Other Outcome Measures:
  1. Change from Baseline in QOL-B scores (excluding Respiratory Symptoms Domain) [ Time Frame: 24-week treatment period ]
    Change from Baseline in score of QOL-B domains (excluding respiratory symptoms domain) at 24-weeks.

  2. Change from Baseline in Leicester Cough Questionnaire (LCQ) score [ Time Frame: 24-week treatment period ]
    Change from Baseline in LCQ score at 24-weeks.

  3. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) score [ Time Frame: 24-week treatment period ]
    Change from Baseline in SGRQ total score at 24- weeks.

  4. Change from Screening of forced vital capacity (FVC) [ Time Frame: At Week 12 and Week 24 ]
    Change from Screening of FVC at Weeks 12 and 24.

  5. Change from Screening of peak expiratory flow rate (PEFR) [ Time Frame: At Week 12 and Week 24 ]
    Change from Screening of PEFR at Weeks 12 and 24.

  6. Change from Screening of forced exploratory flow 25% to 75% (FEF25-75) [ Time Frame: At Week 12 and Week 24 ]
    Change from Screening in FEF25-75 at Weeks 12 and 24.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
  2. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
  3. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion Criteria:

  1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
  2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
  3. Are current smokers
  4. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
  5. Have any acute infections, (including respiratory infections)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218917


Contacts
Contact: Tomoko Shibata +1.908.947.2821 tomoko.shibata@insmed.com
Contact: Kathryn Lunga +1.908.947.4304 kathryn.lunga@insmed.com

Locations
United States, California
NewportNativeMD Recruiting
Newport Beach, California, United States, 92663
Contact: Tiffany Woosley    949-791-8599    tiffany@newportnativemd.com   
Contact: Leslie Frisby    949-791-8599    leslie@newportnativemd.com   
Principal Investigator: Ryan Klein, MD         
United States, Connecticut
UConn Health Center Active, not recruiting
Farmington, Connecticut, United States, 06030-1321
Sponsors and Collaborators
Insmed Incorporated

Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT03218917     History of Changes
Other Study ID Numbers: INS1007-201
2017-002533-32 ( EudraCT Number )
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Insmed Incorporated:
P aeruginosa
bronchiectasis
active neutrophil elastase

Additional relevant MeSH terms:
Fibrosis
Bronchiectasis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases