The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Browse trials for

• Asthma 4,010

Keywords

• chronic asthma

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 642 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Study arms

• Experimental
  1

  Montelukast + Beclomethasone

  Drug: montelukast sodium · Drug: beclomethasone

• Experimental
  2

  Montelukast + Placebo inhaler

  Drug: montelukast sodium · Drug: Placebo inhaler

• Experimental
  3

  Placebo tablet + Beclomethasone

  Drug: beclomethasone · Drug: placebo tablet

• Placebo comparator
  4

  Placebo tablet + Placebo inhaler

  Drug: Placebo inhaler · Drug: placebo tablet

Interventions

• Drugmontelukast sodium

  10 mg tablet taken once daily at bedtime for 16 weeks

  Also known as: MK0476

• Drugbeclomethasone

  200 ug inhaled, taken twice daily for 16 weeks

• DrugPlacebo inhaler

  placebo inhaler taken twice daily for 16 weeks

• Drugplacebo tablet

  placebo tablet taken once daily at bedtime for 16 weeks

Primary outcomes

1. Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma

   Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups

   Time frame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups

2. Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma

   The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms \[from 0 (best) to 6 (worst)\] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.

   Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Secondary outcomes

1. Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use

   Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.

   Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

2. Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma

   Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.

   Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

3. Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only

   Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms \[from 0 (best) to 3 (worst)\] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.

   Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Baseline characteristics

Publications

• Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042. PubMed 10588598 ↗