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Completed

NCT Number: NCT02782312

Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

Inhaled ICS and LABA have proved obvious benefit for asthma or chronic obstructive pulmonary disease (COPD) patients. However, there is presently no clear evidence on the effect of ICS and LABA combined inhaled therapy for non-CF bronchiectasis patients.

This study is designed as a prospective, randomized,control trial. Patients are divided into two groups, one group inhaled with ICS and LABA (Seretide), another group received routine therapy (oxygen uptake, phlegm dissipation, hemostasis postural drainage and naturopathy).The course of treatment is 12 months. All patients underwent reviews at baseline entry to the study and at months 6 and 12 of treatment.

The quality of life (QOL) scores:St George's dyspnea score (SGRQ score), modified british medical reserach council(mMRC score) and COPD assessment test (CAT score); lung function test: forced expiratory volume in one second (FEV1),FEV1% predicted, the ratio of forced expiratory volume in one second and forced vital capacity (FEV1/FVC%); short-acting β2-adrenergic agonist(SABA)use and the incidence of adverse event were monitored throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ICS+LABA

Drug

Seretide is inhaled for one year

Other names: Seretide

routine therapy

Other

routine therapy for one year

Primary outcomes

  1. Quality of life

    Time frame: 12 months

    CAT score

  2. Quality of life

    Time frame: 12 months

    mMRC score

  3. Quality of life

    Time frame: 12 months

    SGRQ score

Secondary outcomes

  1. pulmonary function text

    Time frame: 12 months

    FEV1

  2. pulmonary function text

    Time frame: 12 months

    FEV1% predicted

  3. pulmonary function text

    Time frame: 12 months

    FEV1/FVC

  4. short-acting β2-adrenergic agonist (SABA) used

    Time frame: 12 months

    Number of SABA needed per patient every week

  5. Exacerbations

    Time frame: 12 months

    The times of acute exacerbation during the trial.

  6. sputum microorganism culture

    Time frame: 12 months

    Number of microorganism isolates along the study

  7. Number of patients with adverse events

    Time frame: 12 months

    All of the adverse events occurred in the processing of the trial,especially adverse events associated with inhaled corticosteroids

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 25, 2016
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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