Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma (PAW01)
This study has been completed.
Sponsor:
University of Dundee
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00829257
First received: January 26, 2009
Last updated: June 11, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: HFA-BDP Drug: Fluticasone Drug: Seretide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Beclomethasone dipropionate
Beclomethasone dipropionate monohydrate
Fluticasone propionate
Salmeterol
Fluticasone
Salmeterol xinafoate
U.S. FDA Resources
Further study details as provided by University of Dundee:
Primary Outcome Measures:
- Alveolar nitric oxide [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fine particle steroid inhaler
HFA-BDP plus Fluticasone/Salmeterol Combination
|
Drug: HFA-BDP
HFA-BDP (Qvar) 100ug 2puff b.i.d
Drug: Seretide
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
|
|
Active Comparator: Coarse Particle Inhaler
FP plus Fluticasone/Salmeterol combination
|
Drug: Fluticasone
Fluticasone propionate Accuhaler 250ug b.i.d.
Drug: Seretide
Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
- RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
- Informed consent and ability to perform exhaled nitric oxide assessment.
- Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.
Exclusion Criteria:
- Recent respiratory infection or oral steroid use.
- Pregnancy or lactation.
- Known or suspected contra-indication to any of the IMP's.
- CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829257
Locations
| United Kingdom | |
| Asthma and Allergy Research Group, Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
University of Dundee
Investigators
| Principal Investigator: | Peter A Williamson | University of Dundee |
More Information
Additional Information:
No publications provided
| Responsible Party: | Brian J Lipworth, Professor, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00829257 History of Changes |
| Other Study ID Numbers: | PAW01, Eudract no: 2008-001811-40 |
| Study First Received: | January 26, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Salmeterol Albuterol Fluticasone Fluticasone, salmeterol drug combination |
Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013