Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma (CLE001)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Dundee.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Dundee
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00830505
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: fluticasone/ salmeterol Drug: fluticasone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Cross-Over Study to Demonstrate Superiority of Fluticasone/Salmeterol Over Double the Dose of Fluticasone on Methacholine Hyper-Reactivity in Patients With Persistent, Mild to Moderate Asthma |
Resource links provided by NLM:
Further study details as provided by University of Dundee:
Primary Outcome Measures:
- methacholine challenge [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- spirometry [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
- Bmax and Emax [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
- impulse oscillometry [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
- mannitol challenge [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
- serum ECP [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: No ]
- overnight urinary cortisol creatnine clearance [ Time Frame: before and after a 2 week treatment period ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1: fluticasone/salmeterol
2 puffs twice a day for 2 weeks
|
Drug: fluticasone/ salmeterol
2 puffs twice a day for 2 weeks
Other Name: fluticasone/ salmeterol combination
|
|
Active Comparator: 2: fluticasone
2 puffs twice a day for 2 weeks
|
Drug: fluticasone
2 puffs twice a day for 2 weeks
Other Name: Flixotide
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent given by patient.
- Male or female patients between 18 and 65 years of age inclusive.
- Persistent stable asthmatics (FEV1 > 60%)
- On ≤ 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD)
- Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 %
- In the opinion of the investigator, able and willing to comply with the requirements of the protocol.
Exclusion Criteria:
- Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms.
- Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI
- Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA).
- Females who are pregnant, lactating or planning to become pregnant.
- Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).
- Clinically significant laboratory values, as judged by the investigator.
- Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
- Patients who are scheduled to receive any other investigational drug during the course of the study.
- Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
- Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
- Respiratory tract infection in the previous 2 months.
- Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830505
Contacts
| Contact: karine L Clearie, MBBS, MRCP | 01382 496440 ext 36440 | k.clearie@dundee.ac.uk |
| Contact: Brian J Lipworth, MBchB | 01382496440 ext 36440 | brianlipworth@googlemail.com |
Locations
| United Kingdom | |
| Asthma and Allergy Research Group | |
| Dundee, Angus, United Kingdom, DD1 9SY | |
Sponsors and Collaborators
University of Dundee
Investigators
| Principal Investigator: | Karine L Clearie, MBBS, MRCP | Asthma and Allergy Research Group |
| Study Director: | Brian J Lipworth, MBchB | Asthma and Allergy Research Group |
More Information
No publications provided by University of Dundee
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Karine Clearie, Asthma and Allergy Research Group |
| ClinicalTrials.gov Identifier: | NCT00830505 History of Changes |
| Other Study ID Numbers: | CLE001 |
| Study First Received: | January 27, 2009 |
| Last Updated: | January 27, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Dundee:
|
fluticasone salmeterol bronchoprotection |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases 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 Tocolytic Agents Reproductive Control Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013