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
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent given by patient.
  2. Male or female patients between 18 and 65 years of age inclusive.
  3. Persistent stable asthmatics (FEV1 > 60%)
  4. 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)
  5. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 %
  6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms.
  2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI
  3. 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).
  4. Females who are pregnant, lactating or planning to become pregnant.
  5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).
  6. Clinically significant laboratory values, as judged by the investigator.
  7. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
  8. Patients who are scheduled to receive any other investigational drug during the course of the study.
  9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
  10. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
  11. Respiratory tract infection in the previous 2 months.
  12. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00830505

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

United Kingdom
Asthma and Allergy Research Group
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
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

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:

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 27, 2016