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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_006 | Other Identifier | Merck Registration Number |
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The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast/Salmeterol | Experimental | Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
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| Salmeterol/Montelukast | Experimental | Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast sodium | Drug | Montelukast 5 mg chewable tablet once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Post-exercise Percent (%) Fall in FEV1 | The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20568384 | Derived | Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011. |
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For randomization, patients fulfilled the following criteria:
Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast / Salmeterol | Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period I |
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| Salmeterol xinafoate | Drug | Salmeterol 50 mcg dry powder per actuation inhaled twice daily |
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| Fluticasone propionate | Drug | Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily |
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| Montelukast matching placebo | Drug | Matching placebo to montelukast oral tablet administered once daily. |
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| Salmeterol matching placebo | Drug | Matching placebo to salmeterol dry powder for inhalation administered twice daily |
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| 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
| Maximum FEV1 % Predicted Following First Beta-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
| Time to Recovery to Within 5% of Baseline FEV1 | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
| Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use. | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
| FG001 | Salmeterol / Montelukast | Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period |
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| Period II |
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast / Salmeterol | Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
| BG001 | Salmeterol / Montelukast | Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Area Under the Curve from 0 to 20 minutes (AUC0-20) | Area Under the Curve for percent-change from pre-exercise baseline FEV1 in liters, from 0 to 20 minutes (AUC0-20) | Mean | Standard Deviation | Percent times Minutes |
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| Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use | Mean | Standard Deviation | Percent change from baseline |
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| Maximum FEV1 percent predicted | Mean | Standard Deviation | Percent of predicted value |
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| Maximum percent fall in FEV1 after exercise | Mean | Standard Deviation | Percent change from baseline |
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| Time to recovery | Montelukast / Salmeterol, n=71; Salmeterol / Montelukast, n=70 | Mean | Standard Deviation | Minutes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Post-exercise Percent (%) Fall in FEV1 | The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1. | The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
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| Secondary | Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline. | The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percent times Minutes | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
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| Secondary | Maximum FEV1 % Predicted Following First Beta-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use. | The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percent of predicted value | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
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| Secondary | Time to Recovery to Within 5% of Baseline FEV1 | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge. | The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Median | Inter-Quartile Range | minutes | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
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| Secondary | Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use | The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use. | The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change from baseline | 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) |
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154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M & 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S & 72 took M. Total of 150 pts took M and 150 took S.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Montelukast | Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks. Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. | 1 | 150 | 27 | 150 | ||
| EG001 | Salmeterol | Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks. Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. | 1 | 150 | 21 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Allergy To Plants | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Pertussis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Respiratory Tract Infection Viral | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral Rhinitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Ear Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Skin Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Menstruation Delayed | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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