NCT02782312

Brief Summary

The objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone （ICS and LABA）combined inhaled therapy for non-cystic fibrosis（non-CF）bronchiectasis patients with chronic airflow obstruction. Moreover, subgroup analysis is performed to explore which populations of bronchiectasis patients this treatment is suitable for.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 17, 2016

Last Update Submit

May 25, 2016

Conditions

Bronchiectasis

Keywords

BronchiectasisICS+LABA

Outcome Measures

Primary Outcomes (3)

  • Quality of life

    CAT score

    12 months

  • Quality of life

    mMRC score

    12 months

  • Quality of life

    SGRQ score

    12 months

Secondary Outcomes (7)

  • pulmonary function text

    12 months

  • pulmonary function text

    12 months

  • pulmonary function text

    12 months

  • short-acting β2-adrenergic agonist (SABA) used

    12 months

  • Exacerbations

    12 months

  • +2 more secondary outcomes

Study Arms (2)

ICS+LABA Group

EXPERIMENTAL

Seretide 250，inhalation，twice daily，one year

Drug: ICS+LABA

Control Group

ACTIVE COMPARATOR

routine therapy for one year

Other: routine therapy

Interventions

ICS+LABADRUG

Seretide is inhaled for one year

Also known as: Seretide
ICS+LABA Group
routine therapyOTHER

routine therapy for one year

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable bronchiectasis; have the ability to complete the pulmonary function tests; FEV1/FVC\<70%; ≥2 exacerbations within the past year

You may not qualify if:

  • a cigarette smoking history more than 10 pack-years;cystic fibrosis or traction bronchiectasis due to various pulmonary fibrosis; an active pulmonary mycobacterial infection; fungal infection; active sarcoidosis; active allergic bronchopulmonary aspergillosis (ABPA); asthma as defined by the Global Initiative for Asthma (GINA); patients with severe cardiopulmonary dysfunction; with impaired hepatic or kidney function; with hypogammaglobulinemia or other autoimmune diseases; pregnant or breast-feeding women; or patients with a known intolerance for ICS or LABAs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • Martinez-Garcia MA, Soler-Cataluna JJ, Catalan-Serra P, Roman-Sanchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-468. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.

    PMID: 21778259RESULT

  • Tsang KW, Tan KC, Ho PL, Ooi GC, Ho JC, Mak J, Tipoe GL, Ko C, Yan C, Lam WK, Chan-Yeung M. Inhaled fluticasone in bronchiectasis: a 12 month study. Thorax. 2005 Mar;60(3):239-43. doi: 10.1136/thx.2002.003236.

    PMID: 15741443RESULT

  • Goyal V, Chang AB. Combination inhaled corticosteroids and long-acting beta2-agonists for children and adults with bronchiectasis. Cochrane Database Syst Rev. 2014 Jun 10;2014(6):CD010327. doi: 10.1002/14651858.CD010327.pub2.

    PMID: 24913725RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Jin-Fu Xu

    Shanghai Pulmonary Hospital , Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of respiratory department

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 25, 2016

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

CN(1)