Trial · NCT02635945
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Late Asthmatic Response (LAR) , measured as the fall of the forced expiratory volume (FEV1) between 3 and 10 hours postallergen bronchoprovocation | 3-to-10 hour post-allergen bronchoprovocation. | |
| Secondary | Early Asthmatic Response (EAR), measured as the maximum FEV1 fall from the postdiluent value | within 1 hour post-allergen bronchoprovocation. | |
| Secondary | hyperresponsiveness to AMP in terms of provocative concentration causing a 20% fall (PC20) increment in response to AMP airway challenge | 24-hour post-allergen bronchoprovocation | |
| Secondary | Nitric oxide fraction in exhaled air (FeNO) on post-allergen bronchoprovocation day | 6th treatment period day | |
| Secondary | Total leukocytes per mL in induced sputum on post-allergen bronchoprovocation day | 6th treatment period day | |
| Secondary | Leukocyte differential counts per mL in induced sputum on post-allergen bronchoprovocation day. | 6th treatment period day | Leukocyte subpopulations from cytocentrifuged, stained preparations will be counted and expressed as percentage cell numbers per volume unit. |
| Secondary | Adverse events | 2 Months | The occurrence of adverse events will be monitored through the complete study. Adverse events will be recorded with the following information: severity grade (mild, moderate, severe); suspected/unsuspected relationship to the study drug; duration (date and time of onset, defined as precisely as possible, and end date or if continuing at final exam) |
| Secondary | Vital signs | 9 times during 2 months | Vital signs will include radial artery pulse rate (measured for 60 seconds), and systolic and diastolic blood pressure. Pulse rate and blood pressure will be assessed in the right arm after the patient has rested in the sitting position for at least 5 min. Vital sign values will be recorded as notable if: pulse rate \<40 or \>90 bpm; systolic blood pressure \<90 or \>140 mmHg; diastolic blood pressure \<50 or \>90 mmHg. |
| Secondary | Number of Participants With Abnormal Laboratory Values | 4 times during 2 months | On visits V2+24h, V4+24h and V6+24h, venipuncture will be performed for blood laboratory evaluations. The analysis will be performed at the local laboratory, and will include: hemogram with complete blood counts and differential leukocyte counts; clinical biochemistry including electrolytes (sodium, potassium, chloride), glucose, creatinine, urea, aspartate transaminase (AST), alanine transaminase (ALT), gammaglutamyl transpeptidase (GGT) and bilirubin; and serum immunoglobulin E (IgE) (only on visit V2+24h). |
| Secondary | Physical examination | 7 times during 2 months | |
| Secondary | Electrocardiogram (EKG) | 3 times during 2 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02635945/registered