Trial · NCT01132781
Theophylline in Rhinitis
NCT01132781, Phase 2, Completed, University of East Anglia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Theophylline in Rhinitis. Trials, record NCT01132781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01132781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Theophylline in Rhinitis
- NCT number
- NCT01132781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- University of East Anglia
- Conditions
- Rhinosinusitis, Asthma, Allergic Rhinitis
- Interventions
- Theophylline (Intervention Group), Placebo (Placebo Group)
- First posted
- 2010-05-28
- Last updated
- 2012-08-23
- Other registries' IDs
- eudract:2007-004642-32
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in total nasal symptom score | 18 weeks | The primary endpoint will be the difference in total nasal symptom score between active and placebo treatment periods measured at the clinic |
| Secondary | The difference in domiciliary average total nasal symptom score | 18 weeks | |
| Secondary | The difference in nasal peak inspiratory flow at clinic visit | 18 weeks | Nasal inspiratory flow will be measured using an In-check™ flow meter (Clement Clarke International Ltd, Harlow, UK). After blowing their nose, patients will inspire forcefully from residual volume to total lung capacity with their mouth closed. All measurements will be made while in the sitting position with a good seal around a purpose built facemask. The median of 3 readings will be recorded. For the purposes of the diary card data, these measurements will be recorded at 2200hrs. The average of the last 5 days measurements will be used in the analysis. |
| Secondary | The difference in domiciliary nasal peak inspiratory flow | 18 weeks | Nasal inspiratory flow will be measured using an In-check™ flow meter (Clement Clarke International Ltd, Harlow, UK). After blowing their nose, patients will inspire forcefully from residual volume to total lung capacity with their mouth closed. All measurements will be made while in the sitting position with a good seal around a purpose built facemask. The median of 3 readings will be recorded. For the purposes of the diary card data, these measurements will be recorded at 2200hrs. The average of the last 5 days measurements will be used in the analysis. |
| Secondary | The difference in Sino-Nasal Outcomes Test (SNOT) -22 questionnaire | 18 weeks | The Sino-Nasal Outcomes Test (SNOT) is a validated disease-specific health-related quality of life instrument. It comprises 22 questions and takes less than 5 minute to complete. It is self administered questionnaire. It will be completed at each study visit. |
| Secondary | Secondary Analysis | 18 weeks | A secondary analysis will be undertaken to determine whether there is a difference in primary and secondary endpoints (above) between treatment with theophylline and placebo in patients who smoke versus those who do not smoke. |
| Secondary | Serum theophylline concentration at the end of both placebo or active treatment periods. | 18 weeks | |
| Secondary | Serum urea and electrolyte concentration at the both placebo or active treatment periods | 18 weeks | |
| Secondary | Drug related adverse effects | 18 weeks | |
| Secondary | The difference histone deacetylase activity from epithelial cells obtained from nasal scrapings. | 18 weeks | Nasal scrapings will be taken from the right nostril using a Rhino-probe Nasal Mucosal Curette (Arlington Scientific Inc, Springville, Utah, USA). Two scrapes will be taken under direct vision according to manufacturer's guidelines. These will be taken at visits 3 and 5. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01132781
GET https://conductscience.org/api/trials/v1/NCT01132781/registered