EUCTR2012-000372-42-ES
Active, not recruiting
Phase 1
A Phase IV, open-label, prospective, randomised clinical trial to evaluate the usefulness of measuring nitric oxide in exhaled air in the therapeutic management of adult patients with mild asthma
Fundació per la Recerca i la Docència Sant Joan de Déu0 sitesApril 17, 2012
ConditionsTreatment in non-smoking adult patients with mild persistent atopic bronchial asthmaMedDRA version: 14.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment in non-smoking adult patients with mild persistent atopic bronchial asthma
- Sponsor
- Fundació per la Recerca i la Docència Sant Joan de Déu
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who have previously given their informed consent to participate in the study will be included. a) Aged between 18 and 65 years. b) Initial diagnosis of mild persistent bronchial asthma according to the definition of the latest GEMA guidelines, well controlled with no exacerbations in the previous 3 months, ACT\>20, normal spirometry and negative bronchodilator test. Patients already known and managed in the Pneumology Department of Parc Sanitari Sant Joan de Déu will be included. c) Atopy, defined as: elevated total IgE and/or allergy tests (skin prick or RAST testing) positive for respiratory pneumoallergens and/or peripheral eosinophilia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 14
Exclusion Criteria
- •a) Patients who do not fulfil the criteria defined in the GEMA guidelines for uncontrolled mild persistent bronchial asthma. b) Patients with an obstructive pattern on spirometry explained by another disease: COLD, sequelae of tuberculosis, bronchiolitis, etc. c) Patients who are clinically unstable at the time of inclusion or who have worsened in the 3 months prior to study inclusion. d) Patients who cannot correctly take treatment via the inhaled route. e) Patients with muscular disorders (myasthenia gravis, Parkinson’s). f) Patients who are smokers or ex\-smokers. g) Patients requiring essential treatment which may produce bronchoconstriction of the airways (e.g. beta\-blockers). h) Women who are pregnant or nursing. j) Patients included in any other research protocol.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A prospective, randomised, phase IV, open label clinical trial to study the therapeutic use of buprenorphine 20 mg (BuTrans 20µg/h) matrix transdermal patch in the management of post tonsillectomy pain in adults - PATCH TrialEUCTR2007-006117-16-GBBetsi Cadwaladr University Health Board300
Active, not recruiting
Phase 1
Immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ co-administered with GSK Biologicals’ human rotavirus (HRV) vaccine Rotarix™ (444563) in healthy infants.Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2014-005282-78-Outside-EU/EEAGlaxoSmithKline Biologicals262
Active, not recruiting
Phase 1
A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly according to a 0, 1, 6-month schedule in females aged 18-25 years. - EPI-HPV-111103o medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to be related to the vaccine.EUCTR2007-006651-39-GBGlaxoSmithKline Biologicals100,000
Active, not recruiting
Phase 1
DREAM studyEUCTR2016-004646-29-ESFundación SEIMC-GESIDA64
Active, not recruiting
Phase 1
This study compares clinically and microscopically the response to two treatments, a steroid in cream and a foam that contains a steroid and a vitamin D analogue in patients with plaque psoriasis.Plaque psoriasisTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2017-004451-24-ESFundació Clínic per a la Reserca Biomèdica36