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The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.
The investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. After 6 week's treatment, the children in MF group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance.
Responders were followed up for six months and reassessed. Non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's OXY or its placebo for every second week. After that, the patients were followed for six months and the evaluation was done at different time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mometasone furoate | Active Comparator | In the first treatment stage, 120 children were assigned to mometasone furoate (50μg, 1 puff in each nostril every evening) after two week's run-in period. |
|
| Placebo | Placebo Comparator | In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period. |
|
| Oxymetazoline + Placebo | Active Comparator | Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving Oxymetazoline and placebo. |
|
| Placebo + placebo | Placebo Comparator | Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving placebo and placebo. |
|
| mometasone furoate + Placebo | Active Comparator | Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate | Drug | 50μg, 1 puff in each nostril every evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| symptom score assessed by TNSS scopring system | six months |
| Measure | Description | Time Frame |
|---|---|---|
| adenoid size assessed by nasopharyngoscope （calculated the adenoid area in relation to the nasopharyngeal area） | six months | |
| nasal volume assessd by Acoustic rhinometry | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| renzhong Luo | Guangzhou Women and Children's Medical Center | Study Chair |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 12, 2016 | |
| Unrelease | Yes | |
| Release | Feb 29, 2016 | |
| Reset | Mar 29, 2016 | |
| Release | Aug 11, 2020 | |
| Reset | Aug 20, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 12, 2016 | Yes | |||
| Feb 29, 2016 |
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| mometasone furoate + Oxymetazoline | Active Comparator | Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and Oxymetazoline. |
|
| Placebo | Drug | 1 puff in each nostril every evening |
|
| Oxymetazoline + Placebo | Drug | 1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening |
|
|
| Placebo + placebo | Drug | 1 puff of placebo +1 puff of Placebo in each nostril every evening |
|
|
| mometasone furoate + Placebo | Drug | 1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening |
|
|
| mometasone furoate + Oxymetazoline | Drug | 1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening |
|
|
| Mar 29, 2016 |
| Aug 11, 2020 | Aug 20, 2020 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |