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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICS+LABA Group | Experimental | Seretide 250,inhalation,twice daily,one year |
|
| Control Group | Active Comparator | routine therapy for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICS+LABA | Drug | Seretide is inhaled for one year |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | CAT score | 12 months |
| Quality of life | mMRC score | 12 months |
| Quality of life | SGRQ score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function text | FEV1 | 12 months |
| pulmonary function text | FEV1% predicted | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Fu Xu | Shanghai Pulmonary Hospital , Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21778259 | Result | 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. | |
| 15741443 | Result | 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. |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| routine therapy | Other | routine therapy for one year |
|
| pulmonary function text | FEV1/FVC | 12 months |
| short-acting β2-adrenergic agonist (SABA) used | Number of SABA needed per patient every week | 12 months |
| Exacerbations | The times of acute exacerbation during the trial. | 12 months |
| sputum microorganism culture | Number of microorganism isolates along the study | 12 months |
| Number of patients with adverse events | All of the adverse events occurred in the processing of the trial,especially adverse events associated with inhaled corticosteroids | 12 months |
| 24913725 | Result | 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. |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |